Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection
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|ClinicalTrials.gov Identifier: NCT02437851|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anal Squamous Cell Carcinoma HIV Infection Stage 0 Anal Canal Cancer Stage I Anal Canal Cancer||Procedure: Therapeutic Conventional Surgery||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Surgical removal of SISCCA with quarterly monitoring for recurrence and treatment of anal high-grade squamous intraepithelial lesions.|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Observational and Feasibility Study of Excision of Superficially Invasive Squamous Cell Carcinoma (SISCCA) of the Anal Canal and Perianus in HIV-Infected Persons|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2026|
Experimental: Treatment (surgery)
Participants undergo therapeutic conventional surgery to remove anal or perianal cancer (SISCCA). Any HSIL remaining is treated with the goal for complete eradication in accordance with clinician and participant preference.
Procedure: Therapeutic Conventional Surgery
Undergo surgery to remove anal or perianal cancer (SISCCA)
- The proportion of participants with treatment failure at 2 years will be estimated with the binomial proportion and exact one-sided 95% confidence intervals. [ Time Frame: 2 years after surgery to remove SISCCA ]Treatment failure is specifically defined as the occurrence of distant or any nodal metastases or recurrence of cancer that no longer meets the definition of SISCCA and that cannot be excised with a clear margin or preservation of sphincter function and requires CMT, or those who develop SISCCA recurrence but elect to undergo CMT rather than repeat excision in patients originally treated with excision of anal canal and perianal SISCCA.
- The proportion of participants with incident SISCCA or anal squamous cancers at sites other than the index SISCCA will be estimated using the binomial proportion and its two-sided exact 95% confidence interval. [ Time Frame: 1 year after surgery to remove SISCCA ]Evidence of incident (new) anal squamous cancers or SISCCA at sites other than the index SISCCA treated with surgical excision. The product-limit method will be used to describe the time from treatment enrollment to treatment failure, censoring the time for study participants who do not experience treatment failure.
- The cumulative proportion of study participants who have experienced treatment failure by 3 years will be estimated using the product-limit estimate and its 95% confidence interval using Greenwood's formula. [ Time Frame: 3 years after surgery to remove SISCCA ]
- The rate of treatment related adverse events including non-healing ulcer, fissure, persistent pain and bleeding, stricture, incontinence, and colostomy 6 months after excision of SISCCA. [ Time Frame: 6 months after surgery to remove SISCCA ]
- Collection of clinical specimens (composite) [ Time Frame: Up to 36 months ]Clinical specimens, specifically the index SISCCA and the overlying or adjacent HSIL, and HSIL that did not progress to SISCCA and other clinical data will be collected to create a bank of well-annotated specimens that will enable correlative science: to assess viral factors in HSIL progression to cancer and to identify host factors in HSIL progression to cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437851
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, New York|
|Laser Surgery Care|
|New York, New York, United States, 10011|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Stephen Goldstone||AIDS Associated Malignancies Clinical Trials Consortium|