Molecular Biology of Anal Cancer in HIV-Positive Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00952874|
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : June 25, 2010
The molecular mechanisms involved in squamous cell carcinoma of the anus (SCCA) are poorly elucidated. HIV-positive and renal transplant patients are at high risk for developing SCCA, indicating that immune suppression plays a facilitating role. The investigators previously demonstrated that chromosomal instability (CIN) was more prevalent in SCCA of HIV-negative than HIV-positive patients. Hence, the investigators postulate that microsatellite instability (MSI), another molecular pathway, might be a feature of SCCA progression in the HIV-positive population.
- to determine the prevalence of MSI in paraffin-embedded tumor specimen of 15 patients from the Swiss HIV cohort who underwent surgical excision for SCCA; and
- eventually, to test our hypothesis by assessing the MSI status of SCCA in 15 recently operated HIV-negative patients.
The study is designed in two steps:
- Firstly, the investigators will retrieve tumor specimen from 15 HIV-positive patients, with a biopsy-confirmed diagnosis of SCCA, in three institutions. DNA from tumor and normal tissues will be extracted, and then amplified by PCR. Presence of MSI in tumors will be determined by assessing the microsatellite markers BAT25, BAT26, and CAT25.
- Secondly, the results of molecular analysis will be compared with a population of HIV-negative patients, with the same tumors, using the same detection technique for MSI.
|Condition or disease|
|Carcinoma HIV Infections|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||Microsatellite Instability in Anal Squamous Cell Carcinomas of HIV-Positive Versus HIV-Negative Patients|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2010|
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): NCT00952874
|University Hospital Geneva|
|Genève, Switzerland, 1211|
|Study Chair:||Bernard Hirschel||Swidd HIV cohort|