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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
CAMPO-101 Trial Summary
This trial will compare three different tests to find HSIL in the cervix or anus in patients with HIV: cytology, high-resolution anoscopy, and HPV testing.
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.Check my eligibility
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.See study design
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.
CAMPO-101 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)
Other outcome measures
Artificial intelligence-based algorithm sensitivity, specificity, and negative and positive predictive values for cervical cancers and precancers
CAMPO-101 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
Colposcopy
2009
Completed Phase 3
~64500
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,236,055 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,924,573 Total Patients Enrolled
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)UNKNOWN
1 Previous Clinical Trials
619 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Imaging, biospecimen collection, anoscopy and/or colposcopy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to become involved in this clinical trial at present?
"Affirmative. Clinicaltrials.gov indicates that this research effort, which was first launched on November 30th 2021, is currently seeking participants. The trial aims to enrol 3 000 persons at one particular site."
Answered by AI
What is the current enrollment capacity for this trial?
"Correct. Information on clinicaltrials.gov affirms that this experiment, which was originally posted on November 30th 2021, is currently enrolling participants. Approximately 3000 patients will be admitted from 1 medical facility."
Answered by AI
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