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Completed Not applicable Interventional Accepts healthy volunteers Results available

The Prevent Anal Cancer Palpation Study

ClinicalTrials.gov ID: NCT04090060

Public ClinicalTrials.gov record NCT04090060. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.

Study identification

NCT ID
NCT04090060
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
718 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
25 Years and older
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 16, 2020
Primary completion
Jun 9, 2023
Completion
Jun 9, 2023
Last update posted
Jul 8, 2024

2020 – 2023

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
University of Chicago Chicago Illinois 60637
Medical University of South Carolina Charleston South Carolina 29425
M.D. Anderson Cancer Center Houston Texas 77030
Gordon Crofoot MD Houston Texas 77098

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04090060, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2024 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04090060 live on ClinicalTrials.gov.

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