Biospecimen Collection - Cervical for Cervical Cancer
Condesa Specialized Clinic, Ciudad de México, Mexico
Targeting 5 different conditionsBiospecimen Collection - Cervical +5 moreN/ARecruitingLed by Joel Palefsky, MDResearch Sponsored by University of California, San FranciscoEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 3 years
Awards & highlights
No Placebo-Only Group
Study 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.
Eligible Conditions
- Anal Carcinoma
- Cervical Cancer
- Anal Intraepithelial Neoplasia
- Cervical Neoplasia
- HIV/AIDS
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
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
Biopsy
2014
Completed Phase 4
~1120
Colposcopy
2015
Completed Phase 3
~54500
High Resolution Anoscopy
2010
N/A
~620
Find a site
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,415 Previous Clinical Trials
12,299,446 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,414 Previous Clinical Trials
41,236,263 Total Patients Enrolled
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)UNKNOWN
1 Previous Clinical Trials
600 Total Patients Enrolled
Media Library
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