Screening Tests for Cervical and Anal Cancer in HIV Patients (CAMPO-101 Trial)

Palo Alto (17 mi)

Overseen byJoel Palefsky, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial uses quick tests to find abnormal tissue changes in the cervix or anus in men and women with HIV. These patients are at higher risk for HPV-related cancers. The tests help detect early signs of potential cancer so that further checks and treatments can be done if needed.

Eligibility Criteria

This trial is for adults over 21 with HIV who have not had a hysterectomy, are not pregnant or recently post-partum, and haven't been treated for related lesions in the last 18 months. They must understand the study and agree to participate, have an ECOG performance status of <=1 (or Karnofsky >=70%), documented HIV infection, and be on antiretroviral therapy.

Treatment Details

The trial tests various screening methods like biopsies and imaging techniques to detect high-grade squamous intraepithelial lesions (HSIL) that could lead to cervical or anal cancer in people with HIV. It aims to identify which screenings work best for early detection.

1Treatment groups

Experimental Treatment

Group I: Imaging, biospecimen collection, anoscopy and/or colposcopyExperimental Treatment6 Interventions

Patients undergo collection of cervical images (if applicable), 3 cervical anal swabs (if applicable) and 3 anal swabs for real-time testing of HPV or hrHPV over 90 minutes. Patients with a positive HPV or hrHPV test on undergo biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for LSIL or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual