The Prevent Anal Cancer Palpation Study

NCT04090060 | Completed Results DMC

• 2 other identifiers: PRO00033000R01CA232892-01
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 4

Brief Summary

Anal cancer is a common cancer among men having sex with men (MSM). We will investigate increasing detection of anal canal tumors through self- or partner-palpation of the anal canal among MSM and trans persons. This study in Houston and Chicago will recruit a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged ≥ 25 years, who will be taught to perform an ASE or ACE. After performing the exam in private, the individual's ASE and partner's ACE will then be compared with a clinician's DARE. The assessment will be done at each of two visits, spaced 6-months apart. One-half of persons will be randomized to a practice condition to assess how practice affects accuracy and retention of exam procedure. Our hypothesis is that both ASE and ACE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits.

Conditions

Anal Cancer

Keywords

Anus neoplasm; Digital anal rectal examination; Self anal examination

Outcome Measures

Primary Outcomes (6)

• Concordance Between Self-examination and Clinician Examination

  This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.

  Day 1

• Concordance Between Self-examination and Clinician Examination

  This measure will record the number of concordant digital anal examination results. A concordant result means that the subject and clinician agree as to the presence or absence of an abnormality.

  Day 180.

• Concordance Between Companion Examination and Clinician Examination

  This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.

  Day 1

• Concordance Between Companion Examination and Clinician Examination

  This measure will record the number of concordant digital anal examination results. A concordant result means that the subject's companion and clinician agree as to the presence or absence of an abnormality.

  Day 180

• Number of Persons Who Practice the Self Examination

  This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 180.

  Day 180

• Number of Persons Who Practice the Companion Examination

  This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 180.

  Day 180

Secondary Outcomes (4)

• Measuring the Difference Between Chicago and Houston Self-exam Concordance.

  Day 1

• Measuring the Difference Between Chicago and Houston Companion Exam Concordance.

  Day 1

• Waist Circumference for Persons Doing Self-examinations

  Day 1

• Concordance Between Self-examination and Clinician Examination Stratified by Waist Circumference.

  Day 1

Study Arms (2)

Practice Self-/Companion Exams

EXPERIMENTAL

300 individuals and 50 couples will be randomized to practice arm.

Behavioral: Practice Self-/Companion Exams

Control Arm

OTHER

300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.

Behavioral: Control Arm

Interventions

Practice Self-/Companion Exams BEHAVIORAL

300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.

Practice Self-/Companion Exams

Control Arm BEHAVIORAL

300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.

Control Arm

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Cis-gendered men and transgender persons.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chicago or Houston Metro Residents
• Persons who had sex with men in the prior five years
• Cis-gendered men and transgender persons
• Age: 25 years and over
• Access to medical care for referral or treatment
• Spanish or English speakers/readers
• Individuals or couples
• HIV+ or HIV-
• Persons with or without comorbidities and physical disabilities

You may not qualify if:

• Unresolved health care provider's diagnosis of anal condyloma, hemorrhoids or anal cancer
• DARE in the prior three months
• Plans to move in the following six months

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• University of Chicago: collaborator
• M.D. Anderson Cancer Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Gordon Crofoot MD PA: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Gordon Crofoot MD

Houston, Texas, 77098, United States

Location

Related Publications (2)

• Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa L, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: an observational study. BMJ Public Health. 2024 Jul 12;2(1):e001039. doi: 10.1136/bmjph-2024-001039. eCollection 2024 Jun.

  PMID: 40018098 DERIVED

• Nyitray AG, Rosser BRS, Hazra A, Nitkowski J, Smith D, Brzezinski B, Ridolfi TJ, Schneider JA, Chiao EY, Sanos S, Mkonyi E, Mgopa LR, Ross MW. Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: An observational study. medRxiv [Preprint]. 2024 Feb 1:2024.01.31.24302098. doi: 10.1101/2024.01.31.24302098.

  PMID: 38352524 DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Alan Nyitray, PhD
• Organization: Medical college of Wisconsin

anyitray@mcw.edu

414-955-7701

Study Officials

• Alan Nyitray, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 16, 2019
• Study Start: January 17, 2020
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)