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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. Identifier: NCT00952874
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : June 25, 2010
University of Lausanne Hospitals
University of Zurich
Information provided by:
University Hospital, Geneva

Brief Summary:

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.

Study Aims:

  1. 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
  2. eventually, to test our hypothesis by assessing the MSI status of SCCA in 15 recently operated HIV-negative patients.

Study Design:

The study is designed in two steps:

  1. 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.
  2. 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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Biosie of anal cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV positive and negative patients with biopsy proven squamous cell carcinoma of the anal canal

Inclusion Criteria:

  • Biopsy proven Squamous cell carcinoma of the anus
  • Informed consent

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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 identifier (NCT number): NCT00952874

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University Hospital Geneva
Genève, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
University of Lausanne Hospitals
University of Zurich
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Study Chair: Bernard Hirschel Swidd HIV cohort
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Responsible Party: Pascal Gervaz, Department of Surgery, University Hospital Geneva Identifier: NCT00952874    
Other Study ID Numbers: SCCA/HIV
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: August 2009
Keywords provided by University Hospital, Geneva:
anal cancer
Molecular biology
HIV status
HPV infection
Microsatellite instability
Biopsy proven Squamous Cell carcinoma of the Anus
Squamous Cell carcinoma of the Anus
Additional relevant MeSH terms:
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Microsatellite Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genomic Instability
Pathologic Processes