Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Prevent Anal Cancer Self-Swab Study

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 : Recruiting
First Posted : April 5, 2018
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
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) and transgender persons. 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 affects 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

Detailed Description:
This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men and transpersons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive HRA-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transpersons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.

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
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 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
Persons 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
Persons 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
Persons 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
Persons 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 ]
    Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening

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


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 ]
    Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test)

  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 ]
    Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

  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 ]
    Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire

  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) ]
    Factors associated with HRA compliance as assessed by the Computer-Assisted Self-Interview (CASI)

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


Other Outcome Measures:
  1. Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions. [ Time Frame: 12 months ]
    Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions: The presence of high-risk HPV (human papillomavirus) DNA will be assessed at baseline and at 12 months. High-risk HPV types that are present at both time points determines the presence of persistence of high-risk HPV DNA. HPV DNA persistence will be assessed for its association with high-grade squamous intraepithelial lesions.

  2. Host/viral methylation and its association with high-grade squamous intraepithelial lesions. [ Time Frame: 12 months ]
    Host/viral methylation and its association with high-grade squamous intraepithelial lesions: The presence of host/viral methylation patterns will be assessed at baseline and at 12 months. Methylation patterns that are present at either time point will be assessed for its association with high-grade squamous intraepithelial lesions.



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:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cis males and transgender persons who have sex with men
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be > 25 years of age
  • Sex at birth is male or gender identity is a transgender person
  • Acknowledge sex with men in the last 5 years, or identify as gay or bisexual
  • Understand and be willing to give informed consent
  • Be willing to be randomized and able to comply with the protocol
  • Spanish and/or English speakers/readers, and
  • HIV+ or HIV-

Exclusion Criteria:

  • Not acknowledge sex with men in the past five years and not identify as gay or bisexual
  • Use of anticoagulants other than Aspirin or NSAIDS
  • Prior diagnosis of anal cancer
  • Plans to move within 12 months
  • Not Milwaukee metro residents
  • Not willing to attend one of the designated study clinics at baseline, or
  • Inability to give informed consent

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 Recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Alan G Nyitray, PhD    414-955-7701    anyitray@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Alan G Nyitray, PhD Medical College of Wisconsin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alan Nyitray, PhD, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03489707    
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: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
Time Frame: Data will become available three years after study completion and be available for five years.
Access Criteria: Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.

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 Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Anus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases