Molecular Biology of Anal Cancer in HIV-Positive Patients

This study has been completed.
Sponsor:
Collaborators:
University of Lausanne Hospitals
University of Zurich
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00952874
First received: August 3, 2009
Last updated: June 24, 2010
Last verified: August 2009
  Purpose

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
Carcinoma
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Microsatellite Instability in Anal Squamous Cell Carcinomas of HIV-Positive Versus HIV-Negative Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Biospecimen Retention:   Samples With DNA

Biosie of anal cancer


Estimated Enrollment: 30
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00952874

Locations
Switzerland
University Hospital Geneva
Genève, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
University of Lausanne Hospitals
University of Zurich
Investigators
Study Chair: Bernard Hirschel Swidd HIV cohort
  More Information

No publications provided

Responsible Party: Pascal Gervaz, Department of Surgery, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT00952874     History of Changes
Other Study ID Numbers: SCCA/HIV
Study First Received: August 3, 2009
Last Updated: June 24, 2010
Health Authority: Switzerland: Federal Office of Public Health

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:
HIV Seropositivity
HIV Infections
Acquired Immunodeficiency Syndrome
Carcinoma, Squamous Cell
Infection
Carcinoma
Microsatellite Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Genomic Instability
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014