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 Francisco

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


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

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Completed Phase 3
High Resolution Anoscopy

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

Biospecimen Collection - Cervical Clinical Trial Eligibility Overview. Trial Name: NCT05074264 — N/A
Cervical Cancer Research Study Groups: Imaging, biospecimen collection, anoscopy and/or colposcopy
Cervical Cancer Clinical Trial 2023: Biospecimen Collection - Cervical Highlights & Side Effects. Trial Name: NCT05074264 — N/A
Biospecimen Collection - Cervical 2023 Treatment Timeline for Medical Study. Trial Name: NCT05074264 — N/A

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. 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 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
~1135 spots leftby Dec 2024