Publications

CCSA’s staff has a long history of producing scientific publications focused on clinical trial protocols, cancer research, chemoprevention, imaging in oncology, biomarker development, and related biomedical research topics. We’re proud to showcase a collection of 150+ articles and studies that highlight our contributions to advancing research and innovation in the life sciences field.

Clinical trial protocols

Ramasubramanian S.

In: DeTora L, ed. Regulatory Writing: An Overview, 3rd ed. Rockville, MD: Regulatory Affairs Professionals Society, 2026, p. 69–74.

First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population

Kelleher-Andersson J, Yoon E, Green C, McFarlane C, Bagheri D, Thomas LP, Turner RS.

Alzheimers Res Ther 2025;17(1):185. PMID: 40775373.

Comparing quantitative imaging biomarker alliance volumetric CT classifications with RECIST response categories

Zhao B, Obuchowski N, Yang H, Chou Y, Ma H, Guo P, Tang Y, Schwartz L, Sullivan D.

Radiol Adv. 2025 Jan 6;2(1):umaf001. PMID: 39834611.

Is local review of positron emission tomography scans sufficient in diffuse large B-cell lymphoma clinical trials? A CALGB 50303 analysis

Torka P, Pederson LD, Knopp MV, Poon D, Zhang J, Kahl BS, Higley HR, Kelloff G, Friedberg JW, Schwartz LH, Wilson WH, Leonard JP, Bartlett NL, Schöder H, Ruppert AS.

Cancer Med. 2023 Apr;12(7):8211-8217. PMID: 36799072.

Case studies for overcoming challenges in using big data in cancer

Sweeney SM, Hamadeh HK, Abrams N, Adam SJ, Brenner S, Connors DE, Davis GJ, Fiore LD, Gawel SH, Grossman RL, Hanlon SE, Hsu K, Kelloff GJ, Kirsch IR, Louv B, McGraw D, Meng F, Milgram D, Miller RS, Morgan E, Mukundan L, O’Brien T, Robbins P, Rubin EH, Rubinstein WS, Salmi L, Schaller TH, Shi G, Sigman CC, Srivastava S.

Cancer Res 2023;83(8):1183–90. PMID: 36625851.

Challenges to using big data in cancer

Sweeney SM, Hamadeh HK, Abrams N, Adam SJ, Brenner S, Connors DE, Davis GJ, Fiore L, Gawel SH, Grossman RL, Hanlon SE, Hsu K, Kelloff GJ, Kirsch IR, Louv B, McGraw D, Meng F, Milgram D, Miller RS, Morgan E, Mukundan L, O’Brien T, Robbins P, Rubin EH, Rubinstein WS, Salmi L, Schaller T, Shi G, Sigman CC, Srivastava S.

Cancer Res 2023;83(8):1175–82. PMID: 36625843.

Harnessing imaging tools to guide immunotherapy trials: Summary from the National Cancer Institute Cancer Imaging Steering Committee workshop

Shankar LK, Schöder H, Sharon E, Wolchok J, Knopp MV, Wahl RL, Ellingson BM, Hall NC, Yaffe MJ, Towbin AJ, Farwell MD, Pryma D, Poussaint TY, Wright CL, Schwartz L, Harisinghani M, Mahmood U, Wu AM, Leung D, de Vries EGE, Tang Y, Beach G, Reeves SA.

Lancet Oncol. 2023 Mar;24(3):e133-e143. PMID: 36858729.

Development of droplet digital PCR-based assays to quantify HIV proviral and integrated DNA in brain tissues from viremic individuals with encephalitis and virally suppressed aviremic individuals

Chung HK, Hattler JB, Narola J, Babbar H, Cai Y, Abdel-Mohsen M, Kim WK.

Microbiol Spectr 2022 Jan 12:e0085321. PMID: 35019681.

Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a phase II clinical trial

Ahmed FS, Dercle L, Goldmacher GV, Yang H, Connors D, Tang Y, Karovic S, Zhao B, Carvajal RD, Robert C, Maitland ML, Oxnard GR, Schwartz LH.

Eur Radiol. 2021 Apr;31(4):1853–62. PMID: 32995974.

Minimal residual disease in myeloma: Application for clinical care and new drug registration

Anderson KC, Auclair D, Adam SJ, Agarwal A, Anderson M, Avet-Loiseau H, Bustoros M, Chapman J, Connors DE, Dash A, Di Bacco A, Du L, Facon T, Flores-Montero J, Gay F, Ghobrial IM, Gormley NJ, Gupta I, Higley H, Hillengass J, Kanapuru B, Kazandjian D, Kelloff GJ, Kirsch IR, Kremer B, Landgren O, Lightbody E, Lomas OC, Lonial S, Mateos MV, Montes de Oca R, Mukundan L, Munshi NC, O’Donnell EK, Orfao A, Paiva B, Patel R, Pugh TJ, Ramasamy K, Ray J, Roshal M, Ross JA, Sigman CC, Thoren KL, Trudel S, Ulaner G, Valente N, Weiss BM, Zamagni E, Kumar SK.

Clin Cancer Res. 2021 Oct 1;27(19):5195–212. PMID: 34321279.

Validation of ctDNA quality control materials through a precompetitive collaboration of the Foundation for the National Institutes of Health

Williams PM, Forbes T, P Lund S, Cole KD, He HJ, Karlovich C, Paweletz CP, Stetson D, Yee LM, Connors DE, Keating SM, Destenaves B, Cleveland MH, Lau CJ, Barrett JC, Kelloff GJ, McCormack RT.

JCO Precis Oncol. 2021 Jun 1;5:PO.20.00528. PMID: 34250423.

International liquid biopsy standardization alliance white paper

Connors D, Allen J, Alvarez JD, Boyle J, Cristofanilli M, Hiller C, Keating S, Kelloff G, Leiman L, McCormack R, Merino D, Morgan E, Pantel K, Rolfo C, Serrano MJ, Pia Sanzone A, Schlange T, Sigman C, Stewart M.

Crit Rev Oncol Hematol. 2020 Dec;156:103112. PMID: 33035734.

Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): A biomarker-driven master protocol

Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS.

Lancet Oncol. 2020 Dec;21(12):1589–1601. PMID: 33125909.

Clinical protocols

Ramasubramanian S, Chen J.

In: DeTora L, ed. Regulatory Writing: An Overview. 2nd ed. Rockville, MD: Regulatory Affairs Professionals Society, 2020, p. 71–8.

Enhanced detection of treatment effects on metastatic colorectal cancer with volumetric CT measurements for tumor burden growth rate evaluation

Maitland ML, Wilkerson J, Karovic S, Zhao B, Flynn J, Zhou M, Hilden P, Ahmed FS, Dercle L, Moskowitz CS, Tang Y, Connors DE, Adam SJ, Kelloff G, Gonen M, Fojo T, Schwartz LH, Oxnard GR.

Clin Cancer Res. 2020 Dec 15;26(24):6464–74. PMID: 32988968.

Provider engagement in radiation oncology data science: Workshop report

Jain AK, Aneja S, Fuller CD, Dicker AP, Chung C, Kim E, Kirby JS, Quon H, Lam CJK, Louv WC, Ahern C, Xiao Y, McNutt TR, Housri N, Ennis RD, Kang J, Tang Y, Higley H, Berny-Lang MA, Camphausen KA.

JCO Clin Cancer Inform. 2020 Aug;4:700–10. PMID: 32755458.

Vol-PACT: A foundation for the NIH public-private partnership that supports sharing of clinical trial data for the development of improved imaging biomarkers in oncology

Dercle L, Connors DE, Tang Y, Adam SJ, Gönen M, Hilden P, Karovic S, Maitland M, Moskowitz CS, Kelloff G, Zhao B, Oxnard GR, Schwartz LH.

JCO Clin Cancer Inform 2018;2:1–12. PMID: 30652552.

Opportunities and challenges in implementation of multiparameter single cell analysis platforms for clinical translation

Keating SM, Taylor DL, Plant AL, Litwack ED, Kuhn P, Greenspan EJ, Hartshorn CM, Sigman CC, Kelloff GJ, Chang DD, Friberg G, Lee JSH, Kuida K.

Clin Transl Sci. 2018 May;11(3):267–76. PMID: 29498218.

A QA program for MRD testing demonstrates that systematic education can reduce discordance among experienced interpreters

Keeney M, Wood BL, Hedley BD, DiGiuseppe JA, Stetler-Stevenson M, Paietta E, Lozanski G, Seegmiller AC, Greig BW, Shaver AC, Mukundan L, Higley HR, Sigman CC, Kelloff G, Jessup JM, Borowitz MJ.

Cytometry B Clin Cytom. 2018 Mar;94(2):239–49. Epub 2017 May 5. PMID: 28475275.

Association of minimal residual disease with clinical outcome in pediatric and adult acute lymphoblastic leukemia: A meta-analysis

Berry DA, Zhou S, Higley H, Mukundan L, Fu S, Reaman GH, Wood BL, Kelloff GJ, Jessup JM, Radich JP.

JAMA Oncol. 2017 Jul 13;3(7):e170580. PMID: 28494052.

The role of minimal residual disease testing in myeloma treatment selection and drug development: Current value and future applications

Anderson KC, Auclair D, Kelloff GJ, Sigman CC, Avet-Loiseau H, Farrell AT, Gormley NJ, Kumar SK, Landgren O, Munshi NC, Cavo M, Davies FE, Di Bacco A, Dickey JS, Gutman SI, Higley HR, Hussein MA, Jessup JM, Kirsch IR, Little RF, Loberg RD, Lohr JG, Mukundan L, Omel JL, Pugh TJ, Reaman GH, Robbins MD, Sasser AK, Valente N, Zamagni E. Clin Cancer Res.

2017 Aug 1;23(15):3980–93. PMID: 28428191.

Lessons learned: Transfer of the high-definition circulating tumor cell assay platform to development as a commercialized clinical assay platform

Kuhn P, Keating SM, Baxter GT, Thomas K, Kolatkar A, Sigman CC.

Clin Pharmacol Ther. 2017 Nov;102(5):777–85. PMID: 28160285.

The National Cancer Institute’s PREVENT Cancer Preclinical Drug Development Program: Overview, current projects, animal models, agent development strategies, and molecular targets

Shoemaker RH, Suen CS, Holmes CA, Fay JR, Steele VE.

Semin Oncol. 2016 Feb;43(1):189–97. PMID: 26970137.

Predictive value tools as an aid in chemopreventive agent development

Dunn BK, Steele VE, Fagerstrom RM, Topp CF, Ransohoff D, Cunningham C, Lubet R, Ford LG, Kramer BS.

J Natl Cancer Inst 2015;107(12):djv259. PMID: 26420882.

Activated type 2 innate lymphoid cells regulate beige fat biogenesis

Lee MW, Odegaard JI, Mukundan L, Qiu Y, Molofsky AB, Nussbaum JC, Yun K, Locksley RM, Chawla A.

Cell. 2015 Jan 15;160(1–2):74–87. PMID: 25543153.

Biomarker development in the context of urologic cancers

Kelloff GJ, Sigman CC, Scher HI.

Urol Oncol. 2015 Jun;33(6):295–301. PMID: 25746942.

Lung Master Protocol (Lung-MAP)-A biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400

Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, Schwartz LH, Vokes E, Ramalingam SS, Bradley JD, Sparks D, Zhou Y, Miwa C, Miller VA, Yelensky R, Li Y, Allen JD, Sigal EV, Wholley D, Sigman CC, Blumenthal GM, Malik S, Kelloff GJ, Abrams JS, Blanke CD, Papadimitrakopoulou VA.

Clin Cancer Res. 2015 Apr 1;21(7):1514–24. PMID: 25680375.

Evidence of clinical utility: An unmet need in molecular diagnostics for patients with cancer

Parkinson DR, McCormack RT, Keating SM, Gutman SI, Hamilton SR, Mansfield EA, Piper MA, Deverka P, Frueh FW, Jessup JM, McShane LM, Tunis SR, Sigman CC, Kelloff GJ.

Clin Cancer Res. 2014 Mar 15;20(6):1428–44. PMID: 24634466.

Germline variants and advanced colorectal adenomas: Adenoma prevention with celecoxib trial genome-wide association study

Wang J, Carvajal-Carmona LG, Chu JH, Zauber AG; APC Trial Collaborators; Kubo M, Matsuda K, Dunlop M, Houlston RS, Sieber O, Lipton L, Gibbs P, Martin NG, Montgomery GW, Young J, Baird PN, Ratain MJ, Nakamura Y, Weiss ST, Tomlinson I, Bertagnolli MM.

Clin Cancer Res 2013;19(23):6430–7. PMID: 24084763.

In vitro binding of a radio-labeled positive allosteric modulator for metabotropic glutamate receptor subtype 5

Zysk JR, Spear N, Fieles W, Stein MM, Sygowski LS, King MM, Hoesch V, Hastings R, Brockel B, Do M, Ström P, Gadient R, Chhajlani V, Elmore CS, Maier DL.

Synapse 2013;67:135–44. PMID: 23150216.

Considerations in the development of circulating tumor cell technology for clinical use

Parkinson DR, Dracopoli N, Petty BG, Compton C, Cristofanilli M, Deisseroth A, Hayes DF, Kapke G, Kumar P, Lee JSh, Liu MC, McCormack R, Mikulski S, Nagahara L, Pantel K, Pearson-White S, Punnoose EA, Roadcap LT, Schade AE, Scher HI, Sigman CC, Kelloff GJ.

J Transl Med. 2012 Jul 2;10:138. PMID: 22747748.

Cancer biomarkers: Selecting the right drug for the right patient

Kelloff GJ, Sigman CC.

Nat Rev Drug Discov. 2012 Feb 10;11(3):201–14. PMID: 22322254.

Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis

Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ.

J Sex Med. 2012;9(1):207–12. PMID: 22082303.

4-Piperidin-4-ylidenemethyl-benzamides as δ-opioid receptor agonists for CNS indications: Identifying clinical candidates

Dantzman CL, King MM, Ernst GE, Wang X, McCauley JP Jr, Andisik DW, Brush K, Bui KH, Frietze W, Hoesch V, Liu J, Palmer WE, Spear N, Hudzik TJ, Wesolowski SS.

Bioorg Med Chem Lett 2012;22:1174–8. PMID: 22197137.

Multiparameter exploration of piperazine derivatives as δ-opioid receptor agonists for CNS indications

McCauley JP Jr, Dantzman CL, King MM, Ernst GE, Wang X, Brush K, Palmer WE, Frietze W, Andisik DW, Hoesch V, Doring K, Hulsizer J, Bui KH, Liu J, Hudzik TJ, Wesolowski SS.

Bioorg Med Chem Lett 2012;22:1169–73. PMID: 22197139.

Regulatory approval of cancer risk-reducing (chemopreventive) drugs: Moving what we have learned into the clinic

Meyskens FL Jr, Curt GA, Brenner DE, Gordon G, Herberman RB, Finn O, Kelloff GJ, Khleif SN, Sigman CC, Szabo E; C-Change Chemoprevention Clinical Trials and Biomarkers Subcommittee.

Cancer Prev Res (Phila). 2011 Mar;4(3):311–23. PMID: 21372031.

Discovery of novel positive allosteric modulators of the metabotropic glutamate receptor 5 (mGlu5)

Varnes JG, Marcus AP, Mauger RC, Throner SR, Hoesch V, King MM, Wang X, Sygowski LA, Spear N, Gadient R, Brown DG, Campbell JB.

Bioorg Med Chem Lett 2011;21:1402–06. PMID: 21295468.

Statin use and colorectal adenoma risk: Results from the adenoma prevention with celecoxib trial

Bertagnolli MM, Hsu M, Hawk ET, Eagle CJ, Zauber AG; Adenoma Prevention with Celecoxib (APC) Study Investigators.

Cancer Prev Res (Phila) 2010;3(5):588–96. PMID: 20403998.

Five-year efficacy and safety analysis of the Adenoma Prevention with Celecoxib Trial

Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Breazna A, Kim K, Tang J, Rosenstein RB, Umar A, Bagheri D, Collins NT, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Hawk ET; Adenoma Prevention with Celecoxib Study Investigators.

Cancer Prev Res (Phila) 2009;2(4):310–21. PMID: 19336730.

In vivo near-infrared fluorescence imaging of human colon adenocarcinoma by specific immunotargeting of a tumor-associated mucin

Dacosta RS, Tang Y, Kalliomaki T, Reilly RM, Weersink R, Elford AR, Marcon NE, Wilson BC.

J Innov Opt Health Sci 2009;2:407–22.

Challenges in clinical prostate cancer: Role of imaging

Kelloff GJ, Choyke P, Coffey DS, Scher HI, Wheeler TM, Anderson L, Tatum J, Scardino PT, Harisinghani M, Catalona WJ, Eisenberger MA, Hussain MH, Larson SM, Marberger M, Moul JW, Padhani A, Schnall MD, Sullivan DC, Wahl RL, Cohen JK, Dahut WL, Dicer AP, Ellis RJ, Feleppa EJ, Frenkel V, Getzenberg RH, Gumbs Petty B, Halpern EJ, Higley HR, Hruszkewycz AM, Jacobs P, Jessup JM, Kattan MW, Katz AE, Kock MO, Koutcher JA, Kurdziel KA, Kurhanewicz J, Lucia MS, Menard C, Parnes HL, Petrick N, Pomper MG, Ravizzini G, Sheinfeld A, Sigman CC, Smith MT, Speight JL, Steele VE, Tang Y, Tempany C, Valicenti RK.

AJR Am J Roentgenol 2009;192:1455–70. PMID: 19457806.

A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment

Taube SE, Clark GM, Dancey JE, McShane LM, Sigman CC, Gutman SI.

J Natl Cancer Inst. 2009 Nov 4;101(21):1453–63. PMID: 19855077.

I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy

Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ.

Clin Pharmacol Ther. 2009 Jul;86(1):97–100. PMID: 19440188.

Early detection of oral neoplasia: Watching with new eyes

Kelloff GJ, Sigman CC, Contag CH.

Cancer Prev Res (Phila). 2009 May;2(5):405–8. PMID: 19401527.

Energy homeostasis and cancer prevention: The AMP-activated protein kinase

Fay JR, Steele V, Crowell JA.

Cancer Prev Res (Phila). 2009 Apr;2(4):301–9. PMID: 19336731.

Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: The cross trial safety analysis

Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli M, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E, for the Cross Trial Safety Assessment Group.

Circulation 2008;117(16):2104–13. PMID: 18378608.

Secondary chemoprevention of Barrett’s esophagus with celecoxib: Results of a randomized trial

Heath EI, Canto MA, Piantadosi S, Montgomery E, Weinstein WM, Herman JG, Dannenberg AJ, Yang VW, Shar AO, Hawk E, Forastiere AA, for the Chemoprevention for Barrett’s Esophagus Trial Research Group.

J Natl Cancer Inst 2007;99(7):545–57. PMID: 17405999.

Targeting the AKT protein kinase for cancer chemoprevention

Crowell JA, Steele VE, Fay JR.

Mol Cancer Ther. 2007 Aug;6(8):2139–48. PMID: 17699713.

The mammalian target of rapamycin pathway as a potential target for cancer chemoprevention

Kopelovich L, Fay JR, Sigman CC, Crowell JA.

Cancer Epidemiol Biomarkers Prev. 2007 Jul;16(7):1330–40. PMID: 17626998.

Assessing intraepithelial neoplasia and drug safety in cancer-preventive drug development

Kelloff GJ, Sigman CC.

Nat Rev Cancer. 2007 Jul;7(7):508–18. PMID: 17568791.

FDG-PET lymphoma demonstration project invitational workshop

Kelloff GJ, Sullivan DM, Wilson W, Cheson B, Juweid M, Mills GQ, Zelenetz AD, Horning SJ, Weber W, Sargent DJ, Dodd L, Korn E, Armitage J, Schilsky R, Christian M, O’connor OA, Wang SJ, Farrell AT, Pazdur R, Graham M, Wahl RL, Larson SM, Kostakoglu L, Daube-Witherspoon M, Gastonis C, Siegel BA, Shankar LK, Lee DB, Higley HR, Sigman CC, Carucci D, Timko D, deGennaro LJ, Sigal E, Barker A, Woodcock J.

Acad Radiol. 2007 Mar;14(3):330–9. PMID: 17307666.

Workshop on imaging science development for cancer prevention and preemption

Kelloff GJ, Sullivan DC, Baker H, Clarke LP, Nordstrom R, Tatum JL, Dorfman GS, Jacobs P, Berg CD, Pomper MG, Birrer MJ, Tempero M, Higley HR, Petty BG, Sigman CC, Maley C, Sharma P, Wax A, Ginsberg GG, Dannenberg AJ, Hawk ET, Messing EM, Grossman HB, Harisinghani M, Bigio IJ, Griebel D, Henson DE, Fabian CJ, Ferrara K, Fantini S, Schnall MD, Zujewski JA, Hayes W, Klein EA, DeMarzo A, Ocak I, Ketterling JA, Tempany C, Shtern F, Parnes HL, Gomez J, Srivastava S, Szabo E, Lam S, Seibel EJ, Massion P, McLennan G, Cleary K, Suh R, Burt RW, Pfeiffer RM, Hoffman JM, Roy HK, Wang T, Limburg PJ, El-Deiry WS, Papadimitrakopoulou V, Hittelman WN, MacAulay C, Veltri RW, Solomon D, Jeronimo J, Richards-Kortum R, Johnson KA, Viner JL, Stratton SP, Rajadhyaksha M, Dhawan A; Workshop Program Committee.

Cancer Biomark. 2007;3(1):1–33. PMID: 17655039.

Imaging and oncologic drug development

El-Deiry WS, Sigman CC, Kelloff GJ.

J Clin Oncol. 2006 Jul 10;24(20):3261–73. PMID: 16829650.

Progress in chemoprevention drug development: The promise of molecular biomarkers for prevention of intraepithelial neoplasia and cancer—a plan to move forward

Kelloff GJ, Lippman SM, Dannenberg AJ, Sigman CC, Pearce HL, Reid BJ, Szabo E, Jordan VC, Spitz MR, Mills GB, Papadimitrakopoulou VA, Lotan R, Aggarwal BB, Bresalier RS, Kim J, Arun B, Lu KH, Thomas ME, Rhodes HE, Brewer MA, Follen M, Shin DM, Parnes HL, Siegfried JM, Evans AA, Blot WJ, Chow WH, Blount PL, Maley CC, Wang KK, Lam S, Lee JJ, Dubinett SM, Engstrom PF, Meyskens FL Jr, O’Shaughnessy J, Hawk ET, Levin B, Nelson WG, Hong WK; AACR Task Force on Cancer Prevention.

Clin Cancer Res. 2006 Jun 15;12(12):3661–97. PMID: 16778094.

Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas

Solomon SD, Pfeffer MA, McMurray JJV, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J, for the APC and PreSAP Trial Investigators.

Circulation 2006;114(10):1028–35. PMID: 16943394.

Celecoxib for the prevention of sporadic colorectal adenomas

Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein RB, Wittes J, Corle D, Hess TM, Woloj GM, Boisserie F, Anderson WF, Viner JL, Bagheri D, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Gordon GB, Hawk ET; APC Study Investigators.

N Engl J Med. 2006 Aug 31;355(9):873–84. PMID: 16943400.

The progress and promise of molecular imaging probes in oncologic drug development

Kelloff GJ, Krohn KA, Larson SM, Weissleder R, Mankoff DA, Hoffman JM, Link JM, Guyton KZ, Eckelman WC, Scher HI, O’Shaughnessy J, Cheson BD, Sigman CC, Tatum JL, Mills GQ, Sullivan DC, Woodcock J.

Clin Cancer Res. 2005 Nov 15;11(22):7967–85. PMID: 16299226.

Progress and promise of FDG-PET imaging for cancer patient management and oncologic drug development

Kelloff GJ, Hoffman JM, Johnson B, Scher HI, Siegel BA, Cheng EY, Cheson BD, O’shaughnessy J, Guyton KZ, Mankoff DA, Shankar L, Larson SM, Sigman CC, Schilsky RL, Sullivan DC.

Clin Cancer Res. 2005 Apr 15;11(8):2785–808. PMID: 15837727.

Targeting epigenetic regulatory mechanisms in cancer chemoprevention

Fay JR, Crowell JA, Kopelovich L.

Expert Opin Ther Targets. 2005 Apr;9(2):315–28. PMID: 15934918.

New science-based endpoints to accelerate oncology drug development

Kelloff GJ, Sigman CC.

Eur J Cancer. 2005 Mar;41(4):491–501. PMID: 15737552.

Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention

Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M, Adenoma Prevention with Celecoxib (APC) Study Investigators.

N Engl J Med 2005;352:1071–80. PMID: 15713944.

Correlation of in vitro chemopreventive efficacy data from the human epidermal cell assay with animal efficacy data and clinical trial plasma levels

Elmore E, Siddiqui S, Navidi M, Steele VE, Redpath L.J.

Cell Biochem 2005 Jun 1;95(3):571–88. PMID: 15786488.

Opportunities and challenges for skin cancer chemoprevention

Viner J, Hawk E, Richmond E, Higley H, Umar A.

In: Kelloff G, Sigman C, editors. Cancer Chemoprevention Vol. 2: Strategies for Cancer Chemoprevention. Totowa, NJ: Humana Press, 2005, p. 421–434.

Use of CA-125 in clinical trial evaluation of new therapeutic drugs for ovarian cancer

Rustin GJ, Bast RC Jr, Kelloff GJ, Barrett JC, Carter SK, Nisen PD, Sigman CC, Parkinson DR, Ruddon RW.

Clin Cancer Res. 2004 Jun 1;10(11):3919–26. PMID: 15173101.

Colorectal adenomas: A prototype for the use of surrogate end points in the development of cancer prevention drugs

Kelloff GJ, Schilsky RL, Alberts DS, Day RW, Guyton KZ, Pearce HL, Peck JC, Phillips R, Sigman CC.

Clin Cancer Res. 2004 Jun 1;10(11):3908–18. PMID: 15173100.

Reanalysis of cancer drugs: Old drugs, new tricks

Vande Woude GF, Kelloff GJ, Ruddon RW, Koo HM, Sigman CC, Barrett JC, Day RW, Dicker AP, Kerbel RS, Parkinson DR, Slichenmyer WJ.

Clin Cancer Res. 2004 Jun 1;10(11):3897–907. PMID: 15173099.

Rationale for biomarkers and surrogate end points in mechanism-driven oncology drug development

Park JW, Kerbel RS, Kelloff GJ, Barrett JC, Chabner BA, Parkinson DR, Peck J, Ruddon RW, Sigman CC, Slamon DJ.

Clin Cancer Res. 2004 Jun 1;10(11):3885–96. PMID: 15173098.

Biomarkers, surrogate end points, and the acceleration of drug development for cancer prevention and treatment: An update prologue

Kelloff GJ, Bast RC Jr, Coffey DS, D’Amico AV, Kerbel RS, Park JW, Ruddon RW, Rustin GJ, Schilsky RL, Sigman CC, Vande Woude GF.

Clin Cancer Res. 2004 Jun 1;10(11):3881–4. PMID: 15173097.

Calcium balance in mature male rats with unloaded hindlimbs

Navidi M, Evans J, Wolinsky I, Arnaud SB.

Aviat Space Environ Med 2004 Jun;75(6):483–8. PMID: 15198272.

Survey of Compounds Which Have Been Tested for Carcinogenic Activity: 2001–2002 Volume

Sigman CC, Holmes CA, Lee JR, Navidi M, Kelly E, Little K, Le D, Berenguer H, Smith L, for the National Cancer Institute (US).

NIH Publication No. 98–149. Washington, DC: US Government Printing Office; 2004.

The epigenome as a target for cancer chemoprevention

Kopelovich L, Crowell JA, Fay JR.

J Natl Cancer Inst. 2003 Dec 3;95(23):1747–57. PMID: 14652236.

Fenretinide: A prototype cancer prevention drug

Malone W, Perloff M, Crowell J, Sigman C, Higley H.

Expert Opin Investig Drugs. 2003 Nov;12(11):1829–42. PMID: 14585058.

Is inducible nitric oxide synthase a target for chemoprevention?

Crowell JA, Steele VE, Sigman CC, Fay JR.

Mol Cancer Ther. 2003 Aug;2(8):815–23. PMID: 12939472.

Counterpoint: Because some surrogate end point biomarkers measure the neoplastic process they will have high utility in the development of cancer chemopreventive agents against sporadic cancers

Kelloff GJ, O’Shaughnessy JA, Gordon GB, Hawk ET, Sigman CC.

Cancer Epidemiol Biomarkers Prev. 2003 Jul;12(7):593–6. PMID: 12869396.

Vitamin D and vitamin D analogs as cancer chemopreventive agents

Guyton KZ, Kensler TW, Posner GH.

Nutr Rev. 2003 Jul;61(7):227–38. PMID: 12918875.

Survey of Compounds Which Have Been Tested for Carcinogenic Activity: 1999–2000 Volume

Sigman CC, Holmes CA, Lee JR, Navidi M, Kelly E, Little K, Le D, Berenguer H, Smith L, for the National Cancer Institute (US).

NIH Publications No. 98–149. Washington, DC: US Government Printing Office; 2002.

Chemoprevention strategies in the prostate: An overview

Kelloff GJ, Higley HR, Brawer MK, Lucia MS, Sigman CC, Crawford ED.

Rev Urol. 2002 Spring;4(2):69–77. PMID: 16985658.

Peroxisome proliferator-activated receptor modulators as potential chemopreventive agents

Kopelovich L, Fay JR, Glazer RI, Crowell JA.

Mol Cancer Ther. 2002 Mar;1(5):357–63. Erratum in: Mol Cancer Ther. 2002 May;1(7):564. PMID: 12489852.

Treatment and prevention of intraepithelial neoplasia: An important target for accelerated new agent development

O’Shaughnessy JA, Kelloff GJ, Gordon GB, Dannenberg AJ, Hong WK, Fabian CJ, Sigman CC, Bertagnolli MM, Stratton SP, Lam S, Nelson WG, Meyskens FL, Alberts DS, Follen M, Rustgi AK, Papadimitrakopoulou V, Scardino PT, Gazdar AF, Wattenberg LW, Sporn MB, Sakr WA, Lippman SM, Von Hoff DD.

Clin Cancer Res. 2002 Feb;8(2):314–46. PMID: 11839647.

The calcium endocrine system of adolescent Rhesus monkeys and controls before and after space flight

Arnaud SB, Navidi M, Deftos L, Thierry-Palmer M, Dotsenko R, Bigbee A, Grindeland RE.

Am J Physiol Endocrinol Metab 2002 Mar;282(3): E514–21. PMID: 11832352.

Agents, biomarkers, and cohorts for chemopreventive agent development in prostate cancer

Kelloff GJ, Lieberman R, Steele VE, Boone CW, Lubet RA, Kopelovich L, Malone WA, Crowell JA, Higley HR, Sigman CC.

Urology. 2001 Apr;57(4 Suppl 1):46–51. PMID: 11295594.

Cancer chemoprevention using natural vitamin D and synthetic analogs

Guyton KZ, Kensler TW, Posner GH.

Annu Rev Pharmacol Toxicol. 2001;41:421–42. PMID: 11264464.

Surrogate end-point biomarkers in chemopreventive drug development

Kelloff GJ, Sigman CC, Hawk ET, Johnson KM, Crowell JA, Guyton KZ.

IARC Sci Publ. 2001;154:13–26. PMID: 11220652.

Agent identification and preclinical testing

Crowell JA, Holmes CJ.

Cancer Treat Res. 2001;106:1–30. PMID: 11224999.

Survey of Compounds Which Have Been Tested for Carcinogenic Activity: 1997–1998 Volume

Sigman CC, Holmes CA, Liu Y-J, Doeltz MK, Navidi M, Thompson S, Eisenhauer K, Kelly E, Le D, Smith L, Sevin J, King M, Tran D, Singer DS, Fung VA, Zaika EL, for the National Cancer Institute (US).

NIH Publication No. 98-149. Washington, DC: US Government Printing Office October 2000.

Potential use of lipoxygenase inhibitors for cancer chemoprevention

Steele VE, Holmes CA, Hawk ET, Kopelovich L, Lubet RA, Crowell JA, Sigman CC, Kelloff GJ.

Expert Opin Investig Drugs. 2000 Sep;9(9):2121–38. PMID: 11060797.

Retinoids in chemoprevention and differentiation therapy

Hansen LA, Sigman CC, Andreola F, Ross SA, Kelloff GJ, De Luca LM.

Carcinogenesis. 2000 Jul;21(7):1271–9. PMID: 10874003.

Perspectives on surrogate end points in the development of drugs that reduce the risk of cancer

Kelloff GJ, Sigman CC, Johnson KM, Boone CW, Greenwald P, Crowell JA, Hawk ET, Doody LA.

Cancer Epidemiol Biomarkers Prev. 2000 Feb;9(2):127–37. PMID: 10698472.

Progress in cancer chemoprevention: Development of diet-derived chemopreventive agents

Kelloff GJ, Crowell JA, Steele VE, Lubet RA, Malone WA, Boone CW, Kopelovich L, Hawk ET, Lieberman R, Lawrence JA, Ali I, Viner JL, Sigman CC.

J Nutr. 2000 Feb;130(2S Suppl):467S–471S. PMID: 10721931.

Clinical development of estrogen modulators for breast cancer chemoprevention in premenopausal vs. postmenopausal women

Lawrence JA, Malpas PB, Sigman CC, Kelloff GJ.

J Cell Biochem Suppl. 2000;34:103–14. PMID: 10762022.

Comparative chemopreventive mechanisms of green tea, black tea, and selected polyphenol extracts measured by in vitro bioassays

Steele VE, Kelloff GJ, Balentine D, Boone CW, Mehta R, Bagheri D, Sigman CC, Zhu S, Sharma S.

Carcinogenesis 2000;21:63–7. PMID: 10607735.

Calcium metabolism in Bion 11 monkeys

Arnaud SB, Navidi M, Deftos L, Buckendahl P, Dotsenko MA, Bengtson S, Bigbee A, Grindeland RE.

J Gravit Physiol 2000 Jan;7(1):S153. PMID: 11543447.

Preclinical efficacy studies of green and black tea extracts

Steele VE, Bagheri D, Balentine DA, Boone CW, Mehta R, Morse MA, Sharma S, Sigman CC, Stoner GD, Wargovich MJ, Weisburger JH, Zhu S, Kelloff GJ.

Proc Soc Exptl Biol 1999;220:210–2. PMID: 10202390.

Progress in cancer chemoprevention

Kelloff GJ, Crowell JA, Steele VE, Lubet RA, Boone CW, Malone WA, Hawk ET, Lieberman R, Lawrence JA, Kopelovich L, Ali I, Viner JL, Sigman CC.

Ann N Y Acad Sci. 1999;889:1–13. PMID: 10668477.

Chemoprevention of prostate cancer: Concepts and strategies

Kelloff GJ, Lieberman R, Steele VE, Boone CW, Lubet RA, Kopelovitch L, Malone WA, Crowell JA, Sigman CC.

Eur Urol. 1999;35(5–6):342–50. PMID: 10325487.

Cancer chemoprevention: Progress and promise

Kelloff GJ, Sigman CC, Greenwald P.

Eur J Cancer. 1999 Dec;35(14):2031–8. PMID: 10711244.

Lipoxygenase inhibitors as potential cancer chemopreventives

Steele VE, Holmes CA, Hawk ET, Kopelovich L, Lubet RA, Crowell JA, Sigman CC, Kelloff GJ.

Cancer Epidemiol Biomarkers Prev. 1999 May;8(5):467–83. PMID: 10350444.

Preclinical drug development paradigms for chemopreventives

Steele VE, Boone CW, Lubet RA, Crowell JA, Holmes CA, Sigman CC, Kelloff GJ.

Hematol Oncol Clin North Am. 1998 Oct;12(5):943–61, v-vi. PMID: 9888015.

Development of new cancer chemoprevention agents: Role of pharmacokinetic/pharmacodynamic and intermediate endpoint biomarker monitoring

Lieberman R, Crowell JA, Hawk ET, Boone CW, Sigman CC, Kelloff GJ.

Clin Chem. 1998 Feb;44(2):420–7. PMID: 9474054.

Aromatase inhibitors as potential cancer chemopreventives

Kelloff GJ, Lubet RA, Lieberman R, Eisenhauer K, Steele VE, Crowell JA, Hawk ET, Boone CW, Sigman CC.

Cancer Epidemiol Biomarkers Prev. 1998 Jan;7(1):65–78. PMID: 9456245.

A quantitative structure-toxicity relationships model for the dermal sensitization guinea pig maximization assay

Enslein K, Gombar VK, Blake BW, Maibach HI, Hostynek JJ, Sigman CC, Bagheri D.

Food Chem Toxicol 1997;35:1091–8. PMID: 9463544.

Prevention of liver cancer

Guyton KZ, Kensler TW.

Curr Opin Oncol. 1997 Sep;9(5):492–6. PMID: 9327229.

Farnesyl protein transferase inhibitors as potential cancer chemopreventives

Kelloff GJ, Lubet RA, Fay JR, Steele VE, Boone CW, Crowell JA, Sigman CC.

Cancer Epidemiol Biomarkers Prev. 1997 Apr;6(4):267–82. PMID: 9107432.

Progress in clinical chemoprevention

Kelloff GJ, Hawk ET, Karp JE, Crowell JA, Boone CW, Steele VE, Lubet RA, Sigman CC.

Semin Oncol. 1997 Apr;24(2):241–52. PMID: 9129692.

Perspectives and progress in development of breast cancer chemopreventive drugs

Kelloff GJ, Boone CW, Crowell JA, Nayfield SG, Hawk ET, Steele VE, Lubet RA, Sigman CC.

Prog Clin Biol Res. 1997;396:159–83. PMID: 9108597.

Perspectives on chemoprevention agent selection and short-term clinical prevention trials

Kelloff GJ, Hawk ET, Crowell JA, Boone CW, Steele VE, Lubet RA, Sigman CC.

Eur J Cancer Prev. 1996 Dec;5 Suppl 2:79–85. PMID: 9061299.

Epidermal growth factor receptor tyrosine kinase inhibitors as potential cancer chemopreventives

Kelloff GJ, Fay JR, Steele VE, Lubet RA, Boone CW, Crowell JA, Sigman CC.

Cancer Epidemiol Biomarkers Prev. 1996 Aug;5(8):657–66. PMID: 8824370.

Mechanistic considerations in the evaluation of chemopreventive data

Kelloff GJ, Boone CW, Steele VE, Crowell JA, Lubet RA, Greenwald P, Hawk ET, Fay JR, Sigman CC.

IARC Sci Publ. 1996;(139):203–19. PMID: 8923032.

Use of in vitro assays to predict the efficacy of chemopreventive agents in whole animals

Steele VE, Sharma S, Mehta R, Elmore E, Redpath JL, Rudd C, Bagheri D, Sigman CC, Kelloff GJ.

J Cell Biochem 1996;Suppl 26:29–53. PMID: 9154167.

New agents for cancer chemoprevention

Kelloff GJ, Boone CW, Crowell JA, Steele VE, Lubet RA, Doody LA, Malone WF, Hawk ET, Sigman CC.

J Cell Biochem Suppl. 1996;26:1–28. PMID: 9154166.

Risk biomarkers and current strategies for cancer chemoprevention

Kelloff GJ, Boone CW, Crowell JA, Nayfield SG, Hawk E, Malone WF, Steele VE, Lubet RA, Sigman CC.

J Cell Biochem Suppl. 1996;25:1–14. PMID: 9027592.

Strategy and planning for chemopreventive drug development: Clinical development plans II

Kelloff GJ, Crowell JA, Hawk ET, Steele VE, Lubet RA, Boone CW, Covey JM, Doody LA, Omenn GS, Greenwald P, Hong WK, Parkinson DR, Bagheri D, Baxter GT, Blunden M, Doeltz MK, Eisenhauer KM, Johnson K, Knapp GG, Longfellow DG, Malone WF, Nayfield SG, Seifried HE, Swall LM, Sigman CC.

J Cell Biochem 1996;Suppl 26:54–315. PMID: 9154168:

Cancer chemoprevention agent development strategies for genistein

Steele VE, Pereira MA, Sigman CC, Kelloff GJ.

J Nutr. 1995 Mar;125(3 Suppl):713S–716S. PMID: 7884556.

Strategies for phase II cancer chemoprevention trials: Cervix, endometrium, and ovary

Kelloff GJ, Boone CW, Crowell JA, Nayfield SG, Hawk E, Steele VE, Lubet RA, Sigman CC.

J Cell Biochem Suppl. 1995;23:1–9. PMID: 8747372.

Inhibition of chemical carcinogenesis

Kelloff GJ, Boone CW, Steele VE, Fay JR, Sigman CC.

In: Arcos J, Argus M, Woo Y, eds. Chemical Induction of Cancer: Modulation and Combination Effects. Boston: Birkhäuser Boston, 1995, p. 79–122.

Progress in cancer chemoprevention: Perspectives on agent selection and short-term clinical intervention trials

Kelloff GJ, Boone CW, Steele VE, Crowell JA, Lubet R, Sigman CC.

Cancer Res. 1994 Apr 1;54(7 Suppl):2015s–24s. PMID: 8137331.

Chemoprevention of OH-BBN-induced bladder cancer in mice by oltipraz, alone and in combination with 4-HPR and DFMO

Moon RC, Kelloff GJ, Detrisac CJ, Steele VE, Thomas CF, Sigman CC.

Anticancer Res. 1994 Jan-Feb;14(1A):5–11. PMID: 8166455.

Chemopreventive drug development: Perspectives and progress

Kelloff GJ, Boone CW, Crowell JA, Steele VE, Lubet R, Sigman CC.

Cancer Epidemiol Biomarkers Prev. 1994 Jan–Feb;3(1):85–98. PMID: 8118391.

Surrogate endpoint biomarkers for phase II cancer chemoprevention trials

Kelloff GJ, Boone CW, Crowell JA, Steele VE, Lubet R, Doody LA.

J Cell Biochem Suppl. 1994;19:1–9. PMID: 7823579.

Clinical development plan: Calcium

Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG, Nayfield S, Parkinson DR, Prasad VK, Prorok PC, Sausville EA, Sigman CC.

J Cell Biochem Suppl. 1994;20:86–109. PMID: 7616756.

Clinical development plan: Aspirin