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Self-/Companion Exams for Anal Cancer
N/A
Waitlist Available
Led By Alan Nyitray
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 25 years and over
Cis-gendered men and transgender persons
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180
Awards & highlights
Study Summary
This trial found that anal cancer is common among gay and bisexual men, and is much higher among those who are HIV-positive. There is no currently efficacious treatment for anal precancers. However, professional societies recommend an annual digital ano-rectal exam (DARE) for all men who have sex with men, which is underutilized. Therefore, alternative methods for early detection are needed.
Who is the study for?
This trial is for men who have sex with men (MSM) and transgender individuals, aged 25 or older, living in Chicago or Houston. Participants can be HIV+ or HIV-, with or without other health issues. They must speak/read English or Spanish and not plan to move within six months. Those with recent anal conditions or cancer screenings are excluded.Check my eligibility
What is being tested?
The study tests if teaching MSM and trans persons to perform self- (ASE) or partner-exams (ACE) of the anal canal increases detection of tumors compared to a clinician's exam (DARE). It involves two visits six months apart, with some participants practicing more to see if it improves accuracy.See study design
What are the potential side effects?
Since this trial involves physical exams rather than medication, there are no direct side effects like those associated with drugs. However, discomfort during palpation may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Men and transgender individuals who identify as male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concordance between companion examination and clinician examination
Self-Examination
Number of persons who practice the companion examination
+1 moreSecondary outcome measures
Concordance between self-examination and clinician examination stratified by waist circumference.
Measuring the difference between Chicago and Houston companion exam concordance.
Measuring the difference between Chicago and Houston self-exam concordance.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Practice Self-/Companion ExamsExperimental Treatment1 Intervention
300 individuals and 50 couples will be randomized to practice arm.
Group II: Control ArmExperimental Treatment1 Intervention
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control Arm
2020
Completed Phase 2
~3300
Practice Self-/Companion Exams
2020
N/A
~720
Find a Location
Who is running the clinical trial?
Gordon Crofoot MD PAUNKNOWN
The University of Texas Health Science Center, HoustonOTHER
903 Previous Clinical Trials
320,259 Total Patients Enrolled
University of ChicagoOTHER
1,001 Previous Clinical Trials
817,012 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had sexual intercourse with men in the last five years.Men and transgender individuals who identify as male.People with or without other health conditions or physical limitations.You have undergone a DARE procedure within the past three months.This criteria is incomplete and requires more information to be accurately summarized. Please provide additional details.You can read and speak either Spanish or English.You are planning to move within the next six months.
Research Study Groups:
This trial has the following groups:- Group 1: Practice Self-/Companion Exams
- Group 2: Control Arm
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.
How many people can participate in this experiment at one time?
"Affirmative. The clinical trial has been published on the website since January 17th, 2020 and was most recently updated in October 14th, 2022. This particular study seeks to enroll 800 patients from two distinct locations."
Answered by AI
Is recruitment currently underway for this clinical research?
"Serving as a source of corroborating information, clinicaltrials.gov appears to suggest that patient recruitment for this medical study is still ongoing. This trial was initially posted on the 17th day of January in 2020 and has been updated most recently on 14th October 2022."
Answered by AI
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