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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
Sex at birth is male or gender identity is a transgender person
Spanish and/or English speakers/readers,
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You were assigned male at birth or identify as a transgender person.
Select...
You can speak and/or read Spanish and English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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 more
Other 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

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
604 Previous Clinical Trials
1,162,003 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,022 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,958 Previous Clinical Trials
1,798,086 Total Patients Enrolled

Media Library

Clinic-based human papillomavirus (HPV) DNA screening Clinical Trial Eligibility Overview. Trial Name: NCT03489707 — N/A
Clinic-based human papillomavirus (HPV) DNA screening 2023 Treatment Timeline for Medical Study. Trial Name: NCT03489707 — N/A
Anal Cancer Clinical Trial 2023: Clinic-based human papillomavirus (HPV) DNA screening Highlights & Side Effects. Trial Name: NCT03489707 — N/A
Anal Cancer Research Study Groups: Home-based human papillomavirus (HPV) DNA screening, 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."

Answered by AI
~49 spots leftby Mar 2025