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Home-based human papillomavirus (HPV) DNA screening for Anal Cancer
N/A
Waitlist Available
Led By Alan G Nyitray, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is testing ways to screen for anal cancer among gay, bisexual, and other MSM and transgender persons to see if annual anal cancer screening is effective, what factors are associated with repeated screening, and how it affects a person's decision to have high-resolution anoscopy.
Eligible Conditions
- Anal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Secondary outcome measures
Compliance with annual screening based on HIV status
Compliance with annual screening based on race/ethnicity
Number of participants attending high-resolution anoscopy based on HIV status
+2 moreOther outcome measures
Host/viral methylation and its association with high-grade squamous intraepithelial lesions.
Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based human papillomavirus (HPV) DNA screeningExperimental Treatment1 Intervention
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Group II: Clinic-based human papillomavirus (HPV) DNA screeningActive Control1 Intervention
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based human papillomavirus (HPV) DNA screening
2020
N/A
~260
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,460 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,118 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,976 Previous Clinical Trials
1,789,255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking blood thinners, except for Aspirin or NSAIDs.You were assigned male at birth or identify as a transgender person.You can speak and/or read Spanish and English.You have been diagnosed with anal cancer before.
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based human papillomavirus (HPV) DNA screening
- Group 2: Clinic-based human papillomavirus (HPV) DNA screening
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial still have room to accept new participants?
"Clinicaltrials.gov specifies that this trial, posted on September 1st 2020 and most recently amended October 14th 2022, is not presently recruiting patients; however, 63 other trials are currently in search for participants."
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