Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03489707
Recruitment Status : Not yet recruiting
First Posted : April 5, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Alan Nyitray, PhD, Medical College of Wisconsin

Brief Summary:
The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM). This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this effects a person's decision to have high-resolution anoscopy.

Condition or disease Intervention/treatment Phase
Anal Cancer Behavioral: Home-based human papillomavirus (HPV) DNA screening Behavioral: Clinic-based human papillomavirus (HPV) DNA screening Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
Experimental: Home-based human papillomavirus (HPV) DNA screening
Men randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Behavioral: Home-based human papillomavirus (HPV) DNA screening
Men randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.

Active Comparator: Clinic-based human papillomavirus (HPV) DNA screening
Men randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
Behavioral: Clinic-based human papillomavirus (HPV) DNA screening
Men randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.




Primary Outcome Measures :
  1. Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening [ Time Frame: baseline ]
  2. Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test) [ Time Frame: about a week before the first DNA screening ]
  2. Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire [ Time Frame: about 1 hour after the first DNA screening ]
  3. Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire [ Time Frame: about 1 hour after the 12 month DNA screening ]
  4. Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire [ Time Frame: about 1 hour after the HRA (HRA occurs about 2 weeks after the 12-month DNA screening) ]
    high resolution anoscopy (HRA)

  5. Number of participants who agree to have a high resolution anoscopy (HRA) [ Time Frame: 2 weeks after the 12-month DNA screening ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cis males and transgender women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men (and trans-women) having sex with men in the last 5 years
  • HPV vaccinees will not be excluded
  • Harris County residents (or Houston metro residents with current insurance)

Exclusion Criteria:

  • Men having no sex with men in the last 5 years and trans-men
  • plan to move within 12 months
  • at risk for excessive bleeding
  • a prior diagnosis of anal cancer
  • an ASCUS+ result in the last 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489707


Contacts
Layout table for location contacts
Contact: Alan G Nyitray, PhD 4149557701 anyitray@mcw.edu

Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Alan G Nyitray, PhD    414-955-7701    anyitray@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Baylor College of Medicine
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Alan G Nyitray, PhD Medical College of Wisconsin

Layout table for additonal information
Responsible Party: Alan Nyitray, PhD, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03489707     History of Changes
Other Study ID Numbers: HSC-MS-17-0635
R01CA215403 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alan Nyitray, PhD, Medical College of Wisconsin:
anal cancer
human papillomavirus

Additional relevant MeSH terms:
Layout table for MeSH terms
Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases