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The Prevent Anal Cancer Palpation 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090060
Recruitment Status : Suspended (Will resume when COVID-19-related social distancing is no longer recommended.)
First Posted : September 16, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
University of Chicago
Baylor College of Medicine
The University of Texas Health Science Center, Houston
Gordon Crofoot MD PA
Information provided by (Responsible Party):
Alan Nyitray, PhD, Medical College of Wisconsin

Brief Summary:
Anal cancer is a common cancer among gay, bisexual and other men having sex with men (MSM). Its annual incidence is approximately 50-fold and 5-fold higher among HIV-positive MSM and HIV-negative MSM, respectively, compared to the rest of the general population. Like cervical cancer, it is primarily caused by human papillomaviruses (HPV). Unlike cervical cancer, there is no efficacious treatment for anal precancers as there is for cervical precancers. To date, randomized clinical trials have failed to find an efficacious treatment although other trials continue; thus, professional societies recommend an annual digital ano-rectal exam (DARE) for detection of anal abnormalities, including small tumors, among all MSM. But DARE is underutilized, e.g., most persons, regardless of HIV do not receive an annual DARE and most HIV physicians do not perform the exam. Therefore, alternative methods for early detection are needed because early detection of small tumors is associated with >85% 5-year survival.

Condition or disease Intervention/treatment Phase
Anal Cancer Behavioral: Practice Self-/Companion Exams Behavioral: Control Arm Not Applicable

Detailed Description:

Even though expert opinion recommends annual digital ano-rectal exams (DARE) for detection of anal cancer tumors among men having sex with men (MSM), the procedure is severely underutilized by clinicians and it is not known how to increase utilization. This is problematic in the context of an extremely high incidence of anal cancer among MSM, no proven treatment for anal precancerous lesions, and lack of screening infrastructure for detecting precancerous lesions, even in high-resource countries.

The long-term goal of this study is to decrease morbidity and mortality from anal cancer by increasing detection of anal canal tumors through self- or partner-palpation of the anal canal. Preliminary data indicate these exams are feasible and highly acceptable among MSM. In a diverse sample of 200 MSM, 93% of men correctly classified their anal self-exam (ASE) or anal companion exam (ACE) as either normal or abnormal, and 94% said the exams were acceptable. Given these findings, our overall objective is to determine the viability of the ASE and ACE by assessing exam accuracy and consistency of results in two clinic sites. Accuracy will be defined as concordance between clinician DARE and participant exam. The central 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. We will test the hypothesis with three specific aims: 1) Estimate ASE and ACE sensitivity and specificity; 2) Determine independent factors associated with ASE and ACE concordance; and 3) Determine the impact of ASE, ACE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies among HIV+ and HIV- MSM and transgender persons. The aims will be accomplished with a study in Houston and Chicago with a sample of 100 couples (i.e., 200 partners) and 600 single persons (one-half HIV-positive), aged >=25 years, who will perform a clinician-taught ASE or ACE. The individual's ASE and partner's ACE will then be compared with the clinician's DARE. The assessment will be done at each of two visits, spaced 12-months apart, to assess retention of exam accuracy.

At the end of visit 1, one-half of participants, i.e., 300 individuals and 50 couples (stratified by city) will be randomly selected and encouraged to practice the ASE/ACE on three occasions before visit 2. Persons will pick dates three, six and nine months after visit 1. Staff will record the dates, provide participants written ASE/ACE instructions and elicit practice results from participants. Participants who report pain associated with ASE/ACE at visit 1 will be told to not practice. Study staff will then schedule the 12-month follow-up visit. Visit duration is 70 and 105 minutes for individuals and partners, respectively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomly assigned to groups encouraged to practice anal examination (Experimental) or not encouraged to practice anal examinations (Control).
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Determining the Accuracy of Self and Partner Anal Exams for Detecting Anal Abnormalities.
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
Experimental: Practice Self-/Companion Exams
300 individuals and 50 couples will be randomized to practice arm.
Behavioral: Practice Self-/Companion Exams
300 men and 50 couples will be randomized and encouraged to practice anal exams every four months (four and eight months following Visit 1). Practice results will be elicited by staff. They will return for Visit 2 (12 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, they will record the results. They will have a digital anal Rectal exam by a clinician who will give the subject his results.

Control Arm
300 individuals and 50 couples will neither be encouraged nor discouraged to practice self-/companion exam.
Behavioral: Control Arm
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 (12 months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam, record results and 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.




Primary Outcome Measures :
  1. Concordance between self-examination and clinician examination [ Time Frame: Day 1 ]
    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.

  2. Concordance between self-examination and clinician examination [ Time Frame: Day 365. ]
    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.

  3. Concordance between companion examination and clinician examination [ Time Frame: Day 1 ]
    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.

  4. Concordance between companion examination and clinician examination [ Time Frame: Day 365 ]
    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.

  5. Number of persons who practice the self examination [ Time Frame: Day 365 ]
    This measure will count the number of subjects who practiced the self examination at least one time between days 1 and 365.

  6. Number of persons who practice the companion examination [ Time Frame: Day 365 ]
    This measure will count the number of subjects who practiced the companion examination at least one time between days 1 and 365.


Secondary Outcome Measures :
  1. Measuring the difference between Chicago and Houston self-exam concordance. [ Time Frame: Day 1 ]
    Differences in outcome measures 1-6, 9 and 10 will be compared for subjects living in the Chicago and Houston metropolitan areas.

  2. Measuring the difference between Chicago and Houston companion exam concordance. [ Time Frame: Day 1 ]
    Differences in outcome measures 1-6, 9 and 10 will be compared for companions living in the Chicago and Houston metropolitan areas.

  3. Waist circumference for persons doing self-examinations [ Time Frame: Day 1 ]
    This measure will record subject waist circumference in cm and assess its association with OM 1 on Day 1.



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.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gendered men and transgender persons.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 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): NCT04090060


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Sciences Center
Houston, Texas, United States, 77030
Gordon Crofoot MD
Houston, Texas, United States, 77098
Sponsors and Collaborators
Medical College of Wisconsin
University of Chicago
Baylor College of Medicine
The University of Texas Health Science Center, Houston
Gordon Crofoot MD PA
Investigators
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Principal Investigator: Alan Nyitray Medical College of Wisconsin
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Responsible Party: Alan Nyitray, PhD, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04090060    
Other Study ID Numbers: PRO00033000
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Anus neoplasm
Digital anal rectal examination
Self anal examination
Additional relevant MeSH terms:
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Anus Neoplasms
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