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Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials

NCT00695422 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2020-08-10

No results posted yet for this study

Summary

RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection and squamous intraepithelial lesions and help doctors plan better treatment.

PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.

Conditions

  • Aids-related Malignancies
  • Lymphoma
  • Precancerous Condition
  • Sarcoma

Interventions

GENETIC

polymerase chain reaction

PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.

OTHER

cytology specimen collection procedure

Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.

OTHER

histological technique

Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

PROCEDURE

colposcopic biopsy

Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • J. Michael Berry, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-14
Primary Completion
2017-04-19
Completion
2017-04-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00695422 on ClinicalTrials.gov