Study Summary
This trial studies surgery to treat patients with early-stage anal cancer and HIV.
- Squamous Cell Anal Carcinoma
- Stage I Anal Cancer
- Stage 0 Anal Canal Cancer
- HIV/AIDS
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: 6 months after surgery to remove SISCCA
Trial Safety
Safety Progress
Side Effects for
Trial Design
1 Treatment Group
Treatment (surgery)
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Therapeutic Conventional Surgery · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 16 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Chang, George J., Michael J. Berry, Naomi Jay, Joel M. Palefsky, and Mark L. Welton. 2002. “Surgical Treatment of High-grade Anal Squamous Intraepithelial Lesions”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s10350-004-6219-8.
- Goldstone, Stephen E., Andrew A. Johnstone, and Erin L. Moshier. 2014. “Long-term Outcome of Ablation of Anal High-grade Squamous Intraepithelial Lesions”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/dcr.0000000000000058.
- Kreuter, Alexander, Bettina Hochdorfer, Markus Stücker, Peter Altmeyer, Ulrike Weiland, Markus A Conant, and Norbert H Brockmeyer. 2004. “Treatment of Anal Intraepithelial Neoplasia in Patients with Acquired HIV with Imiquimod 5% Cream”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2003.12.025.
- Schwarz, Julie K., Jacqueline E. Payton, Ramachandran Rashmi, Tao Xiang, Yunhe Jia, Phyllis Huettner, Buck E. Rogers, et al.. 2012. “Pathway-specific Analysis of Gene Expression Data Identifies the Pi3k/akt Pathway as a Novel Therapeutic Target in Cervical Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-11-2485.
- BEAHRS, OLIVER H., and STEPHEN M. WILSON. 1976. “Carcinoma of the Anus”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000658-197610000-00004.
- Ortholan, Cécile, Alain Ramaioli, Didier Peiffert, Antoine Lusinchi, Pascale Romestaing, Laurent Chauveinc, Emmanuel Touboul, et al.. 2005. “Anal Canal Carcinoma: Early-stage Tumors ≤10 Mm (T1 or Tis): Therapeutic Options and Original Pattern of Local Failure After Radiotherapy”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2004.09.060.
- MATHIESEN, O, S BUUS, and M CRAMERS. 2007. “Topical Imiquimod Can Reverse Vulvar Intraepithelial Neoplasia: A Randomised, Double-blinded Study”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2007.06.003.
- Mine, Karina L., Natalia Shulzhenko, Anatoly Yambartsev, Mark Rochman, Gerdine F. O. Sanson, Malin Lando, Sudhir Varma, et al.. 2013. “Gene Network Reconstruction Reveals Cell Cycle and Antiviral Genes as Major Drivers of Cervical Cancer”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/ncomms2693.
- Shiels, Meredith S., Ruth M. Pfeiffer, Anil K. Chaturvedi, Aimee R. Kreimer, and Eric A. Engels. 2012. “Impact of the HIV Epidemic on the Incidence Rates of Anal Cancer in the United States”. JNCI: Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djs371.
- Schmitz, Martina, Corina Driesch, Lars Jansen, Ingo B. Runnebaum, and Matthias Dürst. 2012. “Non-random Integration of the HPV Genome in Cervical Cancer”. Edited by Alejandro H. Corvalan. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0039632.
- Fuchshuber, P. 1997. “Anal Canal and Perianal Epidermoid Cancers”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s1072-7515(97)00094-x.
- Benson, Al B., III, Alan P. Venook, Mahmoud M. Al-Hawary, Lynette Cederquist, Yi-Jen Chen, Kristen K. Ciombor, Stacey Cohen, et al.. 2018. “NCCN Guidelines Insights: Colon Cancer, Version 2.2018”. Journal of the National Comprehensive Cancer Network. Harborside Press, LLC. doi:10.6004/jnccn.2018.0021.
- Marks, Douglas K., and Stephen E. Goldstone. 2012. “Electrocautery Ablation of High-grade Anal Squamous Intraepithelial Lesions in Hiv-negative and Hiv-positive Men Who Have Sex with Men”. JAIDS Journal of Acquired Immune Deficiency Syndromes. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qai.0b013e3182437469.
- Poluri, R M, and S P Higgins. 2005. “Successful Treatment of Penile Bowen's Disease with 5% Imiquimod Cream”. International Journal of STD & AIDS. SAGE Publications. doi:10.1258/0956462054944444.
- Ramoni, Stefano, Marco Cusini, Francesca Gaiani, Luisa Arancio, and Elvio Alessi. 2009. “Penile Intraepithelial Carcinoma Treated with Imiquimod 1% in an Hiv-positive Patient”. Journal of Dermatological Treatment. Informa UK Limited. doi:10.1080/09546630802562435.
- Fox, Paul A, Mayura Nathan, Nicholas Francis, Naveena Singh, Justin Weir, Glen Dixon, Simon E Barton, and Mark Bower. 2010. “A Double-blind, Randomized Controlled Trial of the Use of Imiquimod Cream for the Treatment of Anal Canal High-grade Anal Intraepithelial Neoplasia in Hiv-positive MSM on HAART, with Long-term Follow-up Data Including the Use of Open-label Imiquimod”. Aids. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qad.0b013e32833d466c.
- Huang, Fung Yu, Yvonne K.Y. Kwok, Elizabeth T. Lau, Mary H.Y. Tang, Tong Yow Ng, and Hextan Y.S. Ngan. 2005. “Genetic Abnormalities and HPV Status in Cervical and Vulvar Squamous Cell Carcinomas”. Cancer Genetics and Cytogenetics. Elsevier BV. doi:10.1016/j.cancergencyto.2004.06.002.
- Heselmeyer, K, E Schröck, S du Manoir, H Blegen, K Shah, R Steinbeck, G Auer, and T Ried. 1996. “Gain of Chromosome 3q Defines the Transition from Severe Dysplasia to Invasive Carcinoma of the Uterine Cervix.”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.93.1.479.
- Leonard, Daniel, David Beddy, and Eric Dozois. 2011. “Neoplasms of Anal Canal and Perianal Skin”. Clinics in Colon and Rectal Surgery. Georg Thieme Verlag KG. doi:10.1055/s-0031-1272824.
- Oehler-Jänne, Christoph, Florence Huguet, Sawyna Provencher, Burkhardt Seifert, Laura Negretti, Marc-Oliver Riener, Marta Bonet, Abdelkarim S. Allal, and I. Frank Ciernik. 2008. “Hiv-specific Differences in Outcome of Squamous Cell Carcinoma of the Anal Canal: A Multicentric Cohort Study of Hiv-positive Patients Receiving Highly Active Antiretroviral Therapy”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.15.2348.
- Zilli, Thomas, Ulrike Schick, Mahmut Ozsahin, Pascal Gervaz, Arnaud D. Roth, and Abdelkarim S. Allal. 2012. “Node-negative T1–T2 Anal Cancer: Radiotherapy Alone or Concomitant Chemoradiotherapy?”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2011.09.015.
- Goldstone, Robert N., Andrew B. Goldstone, James Russ, and Stephen E. Goldstone. 2011. “Long-term Follow-up of Infrared Coagulator Ablation of Anal High-grade Dysplasia in Men Who Have Sex with Men”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/dcr.0b013e318227833e.
- Wexler, Ann, Anthony M. Berson, Stephen E. Goldstone, Roger Waltzman, Jason Penzer, Olivier G. Maisonet, Bill McDermott, and John Rescigno. 2008. “Invasive Anal Squamous-cell Carcinoma in the Hiv-positive Patient: Outcome in the Era of Highly Active Antiretroviral Therapy”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s10350-007-9154-7.
- Darragh, Teresa M., Terence J. Colgan, J. Thomas Cox, Debra S. Heller, Michael R. Henry, Ronald D. Luff, Timothy McCalmont, et al.. 2012. “The Lower Anogenital Squamous Terminology Standardization Project for Hpv-associated Lesions”. Journal of Lower Genital Tract Disease. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/lgt.0b013e31825c31dd.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Pineda, Carlos E., J. Michael Berry, Naomi Jay, Joel M. Palefsky, and Mark L. Welton. 2008. “High-resolution Anoscopy Targeted Surgical Destruction of Anal High-grade Squamous Intraepithelial Lesions: A Ten-year Experience”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s10350-008-9233-4.
- Ortholan, Cécile, Michel Resbeut, Jean-Michel Hannoun-Levi, Eric Teissier, Jean-Pierre Gerard, Philippe Ronchin, Audrey Zaccariotto, et al.. 2012. “Anal Canal Cancer: Management of Inguinal Nodes and Benefit of Prophylactic Inguinal Irradiation (CORS-03 Study)”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2011.02.010.
- Goldstone, Stephen E., Joshua S. Hundert, and Jeff W. Huyett. 2007. “Infrared Coagulator Ablation of High-grade Anal Squamous Intraepithelial Lesions in Hiv-negative Males Who Have Sex with Males”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s10350-006-0874-x.
- Stier, Elizabeth A, Stephen E Goldstone, J Michael Berry, Lori A Panther, Naomi Jay, Susan E Krown, Jeannette Lee, and Joel M Palefsky. 2008. “Infrared Coagulator Treatment of High-grade Anal Dysplasia in Hiv-infected Individuals”. JAIDS Journal of Acquired Immune Deficiency Syndromes. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/qai.0b013e3181582d93.
- Kreuter, Alexander, Anja Potthoff, Norbert H. Brockmeyer, Thilo Gambichler, Markus Stücker, Peter Altmeyer, Jochen Swoboda, Herbert Pfister, and Ulrike Wieland. 2008. “Imiquimod Leads to a Decrease of Human Papillomavirus DNA and to a Sustained Clearance of Anal Intraepithelial Neoplasia in Hiv-infected Men”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1038/jid.2008.24.
- Schlecht, Nicolas F., Robert D. Burk, Joel M. Palefsky, Howard Minkoff, Xiaonan Xue, L. Stewart Massad, Melanie Bacon, et al.. 2005. “Variants of Human Papillomaviruses 16 and 18 and Their Natural History in Human Immunodeficiency Virus-positive Women”. Journal of General Virology. Microbiology Society. doi:10.1099/vir.0.81060-0.
- Maiman, M. 1999. “Vaginal 5-fluorouracil for High-grade Cervical Dysplasia in Human Immunodeficiency Virus Infection: A Randomized Trial”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(99)00407-x.
- Steele, Scott R., Madhulika G. Varma, Genevieve B. Melton, Howard M. Ross, Janice F. Rafferty, and W. Donald Buie. 2012. “Practice Parameters for Anal Squamous Neoplasms”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/dcr.0b013e318255815e.
- Richel, O., U. Wieland, H.J.C. De Vries, N.H. Brockmeyer, C. Van Noesel, A. Potthoff, J.M. Prins, and A. Kreuter. 2010. “Topical 5-fluorouracil Treatment of Anal Intraepithelial Neoplasia in Human Immunodeficiency Virus-positive Men”. British Journal of Dermatology. Wiley. doi:10.1111/j.1365-2133.2010.09982.x.
- Richel, Olivier, Henry JC de Vries, Carel JM van Noesel, Marcel GW Dijkgraaf, and Jan M Prins. 2013. “Comparison of Imiquimod, Topical Fluorouracil, and Electrocautery for the Treatment of Anal Intraepithelial Neoplasia in Hiv-positive Men Who Have Sex with Men: An Open-label, Randomised Controlled Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(13)70067-6.
- de Sanjose, Silvia, Wim GV Quint, Laia Alemany, Daan T Geraets, Jo Ellen Klaustermeier, Belen Lloveras, Sara Tous, et al.. 2010. “Human Papillomavirus Genotype Attribution in Invasive Cervical Cancer: A Retrospective Cross-sectional Worldwide Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(10)70230-8.
- Meyerson, Matthew, Stacey Gabriel, and Gad Getz. 2010. “Advances in Understanding Cancer Genomes Through Second-generation Sequencing”. Nature Reviews Genetics. Springer Science and Business Media LLC. doi:10.1038/nrg2841.
- Heselmeyer, K, S du Manoir, H Blegen, B Friberg, C Svensson, E Schröck, T Veldman, K Shah, G Auer, and T Ried. 1997. “A Recurrent Pattern of Chromosomal Aberrations and Immunophenotypic Appearance Defines Anal Squamous Cell Carcinomas”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/bjc.1997.547.
- Graham, Bruce D., Allen B. Jetmore, Jerry E. Foote, and Kirk L. Arnold. 2005. “Topical 5-fluorouracil in the Management of Extensive Anal Bowen's Disease: A Preferred Approach”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s10350-004-0901-8.
- van Seters, Manon, Marc van Beurden, and Anton J.M. de Craen. 2005. “Is the Assumed Natural History of Vulvar Intraepithelial Neoplasia III Based on Enough Evidence? A Systematic Review of 3322 Published Patients”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2005.02.012.
- Mahto, M, M Nathan, and C O'Mahony. 2010. “More Than a Decade On: Review of the Use of Imiquimod in Lower Anogenital Intraepithelial Neoplasia”. International Journal of STD & AIDS. SAGE Publications. doi:10.1258/ijsa.2009.009309.
- Wagstaff, Antona J, and Caroline M Perry. 2007. “Topical Imiquimod”. Drugs. Springer Science and Business Media LLC. doi:10.2165/00003495-200767150-00006.
- Da Costa, Maria M., Charissa J. Hogeboom, Elizabeth A. Holly, and Joel M. Palefsky. 2002. “Increased Risk of High‐grade Anal Neoplasia Associated with a Human Papillomavirus Type 16 E6 Sequence Variant”. The Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1086/340125.
- Wingo, Shana N., Teresa D. Gallardo, Esra A. Akbay, Mei-Chi Liang, Cristina M. Contreras, Todd Boren, Takeshi Shimamura, et al.. 2009. “Somatic LKB1 Mutations Promote Cervical Cancer Progression”. Edited by Syed A. Aziz. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0005137.
- Deshmukh, Ashish A, Ryan Suk, Meredith S Shiels, Kalyani Sonawane, Alan G Nyitray, Yuxin Liu, Michael M Gaisa, Joel M Palefsky, and Keith Sigel. 2019. “Recent Trends in Squamous Cell Carcinoma of the Anus Incidence and Mortality in the United States, 2001–2015”. JNCI: Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djz219.
- Berry, J. Michael, Joel M. Palefsky, Naomi Jay, Su-Chun Cheng, Teresa M. Darragh, and Peter V. Chin-Hong. 2009. “Performance Characteristics of Anal Cytology and Human Papillomavirus Testing in Patients with High-resolution Anoscopy-guided Biopsy of High-grade Anal Intraepithelial Neoplasia”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/dcr.0b013e31819793d9.
- Gagne, S Eric, Ronald Jensen, Anne Polvi, Maria Da Costa, David Ginzinger, Jimmy T Efird, Elizabeth A Holly, Tere Darragh, and Joel M Palefsky. 2005. “High-resolution Analysis of Genomic Alterations and Human Papillomavirus Integration in Anal Intraepithelial Neoplasia”. JAIDS Journal of Acquired Immune Deficiency Syndromes. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.qai.0000179460.61987.33.
- Chai, Christy Y., Hop S. Tran Cao, Samir Awad, and Nader N. Massarweh. 2018. “Management of Stage I Squamous Cell Carcinoma of the Anal Canal”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2017.3151.
- FALKSON, G., and E. J. SCHULZ. 1962. “Skin Changes in Patients Treated with 5-fluorouracil.”. British Journal of Dermatology. Wiley. doi:10.1111/j.1365-2133.1962.tb13497.x.
- Megill, Christina, and Timothy Wilkin. 2017. “Topical Therapies for the Treatment of Anal High-grade Squamous Intraepithelial Lesions”. Seminars in Colon and Rectal Surgery. Elsevier BV. doi:10.1053/j.scrs.2017.04.006.
- Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Stucker M, Altmeyer P, Swoboda J, Pfister H, Wieland U; German Competence Network HIV/AIDS. Imiquimod leads to a decrease of human papillomavirus DNA and to a sustained clearance of anal intraepithelial neoplasia in HIV-infected men. J Invest Dermatol. 2008 Aug;128(8):2078-83. doi: 10.1038/jid.2008.24. Epub 2008 Feb 14.
- de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menendez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andujar M, Castellsague X, Sanchez GI, Nowakowski AM, Bornstein J, Munoz N, Bosch FX; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. Epub 2010 Oct 15.
- Steele SR, Varma MG, Melton GB, Ross HM, Rafferty JF, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for anal squamous neoplasms. Dis Colon Rectum. 2012 Jul;55(7):735-49. doi: 10.1097/DCR.0b013e318255815e. No abstract available.
- van Seters M, van Beurden M, de Craen AJ. Is the assumed natural history of vulvar intraepithelial neoplasia III based on enough evidence? A systematic review of 3322 published patients. Gynecol Oncol. 2005 May;97(2):645-51. doi: 10.1016/j.ygyno.2005.02.012.
- Mathiesen O, Buus SK, Cramers M. Topical imiquimod can reverse vulvar intraepithelial neoplasia: a randomised, double-blinded study. Gynecol Oncol. 2007 Nov;107(2):219-22. doi: 10.1016/j.ygyno.2007.06.003. Epub 2007 Jul 25.
- Kreuter A, Hochdorfer B, Stucker M, Altmeyer P, Weiland U, Conant MA, Brockmeyer NH. Treatment of anal intraepithelial neoplasia in patients with acquired HIV with imiquimod 5% cream. J Am Acad Dermatol. 2004 Jun;50(6):980-1. doi: 10.1016/j.jaad.2003.12.025. No abstract available.
- Goldstone SE, Hundert JS, Huyett JW. Infrared coagulator ablation of high-grade anal squamous intraepithelial lesions in HIV-negative males who have sex with males. Dis Colon Rectum. 2007 May;50(5):565-75. doi: 10.1007/s10350-006-0874-x.
- Chang GJ, Berry JM, Jay N, Palefsky JM, Welton ML. Surgical treatment of high-grade anal squamous intraepithelial lesions: a prospective study. Dis Colon Rectum. 2002 Apr;45(4):453-8. doi: 10.1007/s10350-004-6219-8.
- FALKSON G, SCHULZ EJ. Skin changes in patients treated with 5-fluorouracil. Br J Dermatol. 1962 Jun;74:229-36. doi: 10.1111/j.1365-2133.1962.tb13497.x. No abstract available.
- Maiman M, Watts DH, Andersen J, Clax P, Merino M, Kendall MA. Vaginal 5-fluorouracil for high-grade cervical dysplasia in human immunodeficiency virus infection: a randomized trial. Obstet Gynecol. 1999 Dec;94(6):954-61. doi: 10.1016/s0029-7844(99)00407-x.
- Ramoni S, Cusini M, Gaiani F, Arancio L, Alessi E. Penile intraepithelial carcinoma treated with imiquimod 1% in an HIV-positive patient. J Dermatolog Treat. 2009;20(3):177-8. doi: 10.1080/09546630802562435. No abstract available.
- Da Costa MM, Hogeboom CJ, Holly EA, Palefsky JM. Increased risk of high-grade anal neoplasia associated with a human papillomavirus type 16 E6 sequence variant. J Infect Dis. 2002 May 1;185(9):1229-37. doi: 10.1086/340125. Epub 2002 Apr 16.
- Graham BD, Jetmore AB, Foote JE, Arnold LK. Topical 5-fluorouracil in the management of extensive anal Bowen's disease: a preferred approach. Dis Colon Rectum. 2005 Mar;48(3):444-50. doi: 10.1007/s10350-004-0901-8.
- Gagne SE, Jensen R, Polvi A, Da Costa M, Ginzinger D, Efird JT, Holly EA, Darragh T, Palefsky JM. High-resolution analysis of genomic alterations and human papillomavirus integration in anal intraepithelial neoplasia. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):182-9. doi: 10.1097/01.qai.0000179460.61987.33.
- Heselmeyer K, Schrock E, du Manoir S, Blegen H, Shah K, Steinbeck R, Auer G, Ried T. Gain of chromosome 3q defines the transition from severe dysplasia to invasive carcinoma of the uterine cervix. Proc Natl Acad Sci U S A. 1996 Jan 9;93(1):479-84. doi: 10.1073/pnas.93.1.479.
- Oehler-Janne C, Huguet F, Provencher S, Seifert B, Negretti L, Riener MO, Bonet M, Allal AS, Ciernik IF. HIV-specific differences in outcome of squamous cell carcinoma of the anal canal: a multicentric cohort study of HIV-positive patients receiving highly active antiretroviral therapy. J Clin Oncol. 2008 May 20;26(15):2550-7. doi: 10.1200/JCO.2007.15.2348. Epub 2008 Apr 21.
- Poluri RM, Higgins SP. Successful treatment of penile Bowen's disease with 5% imiquimod cream. Int J STD AIDS. 2005 Sep;16(9):649. doi: 10.1258/0956462054944444. No abstract available.
- Heselmeyer K, Macville M, Schrock E, Blegen H, Hellstrom AC, Shah K, Auer G, Ried T. Advanced-stage cervical carcinomas are defined by a recurrent pattern of chromosomal aberrations revealing high genetic instability and a consistent gain of chromosome arm 3q. Genes Chromosomes Cancer. 1997 Aug;19(4):233-40.
- Wexler A, Berson AM, Goldstone SE, Waltzman R, Penzer J, Maisonet OG, McDermott B, Rescigno J. Invasive anal squamous-cell carcinoma in the HIV-positive patient: outcome in the era of highly active antiretroviral therapy. Dis Colon Rectum. 2008 Jan;51(1):73-81. doi: 10.1007/s10350-007-9154-7. Epub 2007 Dec 8.
- Mahto M, Nathan M, O'Mahony C. More than a decade on: review of the use of imiquimod in lower anogenital intraepithelial neoplasia. Int J STD AIDS. 2010 Jan;21(1):8-16. doi: 10.1258/ijsa.2009.009309.
- Schmitz M, Driesch C, Jansen L, Runnebaum IB, Durst M. Non-random integration of the HPV genome in cervical cancer. PLoS One. 2012;7(6):e39632. doi: 10.1371/journal.pone.0039632. Epub 2012 Jun 27.
- Meyerson M, Gabriel S, Getz G. Advances in understanding cancer genomes through second-generation sequencing. Nat Rev Genet. 2010 Oct;11(10):685-96. doi: 10.1038/nrg2841.
- Chai CY, Tran Cao HS, Awad S, Massarweh NN. Management of Stage I Squamous Cell Carcinoma of the Anal Canal. JAMA Surg. 2018 Mar 1;153(3):209-215. doi: 10.1001/jamasurg.2017.3151. Erratum In: JAMA Surg. 2018 May 23;153(7):692.
- Klas JV, Rothenberger DA, Wong WD, Madoff RD. Malignant tumors of the anal canal: the spectrum of disease, treatment, and outcomes. Cancer. 1999 Apr 15;85(8):1686-93. doi: 10.1002/(sici)1097-0142(19990415)85:83.0.co;2-7.
- Heselmeyer K, du Manoir S, Blegen H, Friberg B, Svensson C, Schrock E, Veldman T, Shah K, Auer G, Ried T. A recurrent pattern of chromosomal aberrations and immunophenotypic appearance defines anal squamous cell carcinomas. Br J Cancer. 1997;76(10):1271-8. doi: 10.1038/bjc.1997.547.
- Darragh TM, Colgan TJ, Cox JT, Heller DS, Henry MR, Luff RD, McCalmont T, Nayar R, Palefsky JM, Stoler MH, Wilkinson EJ, Zaino RJ, Wilbur DC; Members of LAST Project Work Groups. The Lower Anogenital Squamous Terminology Standardization Project for HPV-Associated Lesions: background and consensus recommendations from the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology. J Low Genit Tract Dis. 2012 Jul;16(3):205-42. doi: 10.1097/LGT.0b013e31825c31dd. Erratum In: J Low Genit Tract Dis. 2013 Jul;17(3):368.
- Ortholan C, Ramaioli A, Peiffert D, Lusinchi A, Romestaing P, Chauveinc L, Touboul E, Peignaux K, Bruna A, de La Roche G, Lagrange JL, Alzieu C, Gerard JP. Anal canal carcinoma: early-stage tumors
- Beahrs OH, Wilson SM. Carcinoma of the anus. Ann Surg. 1976 Oct;184(4):422-8. doi: 10.1097/00000658-197610000-00004.
- Ortholan C, Resbeut M, Hannoun-Levi JM, Teissier E, Gerard JP, Ronchin P, Zaccariotto A, Minsat M, Benezery K, Francois E, Salem N, Ellis S, Azria D, Champetier C, Gross E, Cowen D. Anal canal cancer: management of inguinal nodes and benefit of prophylactic inguinal irradiation (CORS-03 Study). Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1988-95. doi: 10.1016/j.ijrobp.2011.02.010. Epub 2011 May 11.
- Wagstaff AJ, Perry CM. Topical imiquimod: a review of its use in the management of anogenital warts, actinic keratoses, basal cell carcinoma and other skin lesions. Drugs. 2007;67(15):2187-210. doi: 10.2165/00003495-200767150-00006.
- Stier EA, Goldstone SE, Berry JM, Panther LA, Jay N, Krown SE, Lee J, Palefsky JM. Infrared coagulator treatment of high-grade anal dysplasia in HIV-infected individuals: an AIDS malignancy consortium pilot study. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):56-61. doi: 10.1097/QAI.0b013e3181582d93.
- Fuchshuber PR, Rodriguez-Bigas M, Weber T, Petrelli NJ. Anal canal and perianal epidermoid cancers. J Am Coll Surg. 1997 Nov;185(5):494-505. doi: 10.1016/s1072-7515(97)00094-x. Erratum In: J Am Coll Surg 1998 Jan;186(1):112.
- 2015. "Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02437851.
Frequently Asked Questions
What is the size of this medical study's participant base?
"The Emmes Company, LLC is supervising this trial from multiple locations including Boston Medical Center in Massachusetts and University of California, San Francisco in Cali. In order to execute the study 20 patients that meet all predetermined inclusion criteria are needed." - Anonymous Online Contributor
Has the FDA accepted Therapeutic Conventional Surgery as a legitimate therapeutic option?
"Our team at Power estimated the safety of Therapeutic Conventional Surgery to be a 2 based on existing evidence. As this is currently in Phase 2, there are some data points attesting to its relative security but no studies demonstrating efficacy." - Anonymous Online Contributor
Is this research program still recruiting participants?
"Upon review of the details provided on clinicaltrials.gov, it is evident that this medical trial has been recruiting patients since April 1st 2015 and that its parameters have recently been updated on September 20th 2022." - Anonymous Online Contributor
How far-reaching is this medical experiment with regard to geographical locale?
"This clinical trial is currently operating at 5 different sites, three of which can be found in Boston, San Francisco and the Bronx. There are also 2 additional locations offering this medication." - Anonymous Online Contributor