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

N/A

Recruiting

Led By Joel Palefsky, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from interventions may include discomfort or pain during biopsy procedures, bleeding or infection at the biopsy site, anxiety from undergoing diagnostic tests, and possible false positive/negative results leading to emotional distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)

Other study objectives

Artificial intelligence-based algorithm sensitivity, specificity, and negative and positive predictive values for cervical cancers and precancers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High Resolution Anoscopy

2010

N/A

~620

Biopsy

2014

Completed Phase 4

~1090