The Prevent Anal Cancer Palpation Study

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    800
  • sponsor
    Medical College of Wisconsin
Updated on 25 January 2021

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.

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.

Details
Condition Rectal Cancer, Anal Cancer, anal carcinoma
Treatment Control Arm, Practice Self-/Companion Exams
Clinical Study IdentifierNCT04090060
SponsorMedical College of Wisconsin
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 25 yrs?
Are you male?
Do you have any of these conditions: Anal Cancer or Rectal Cancer?
Do you have any of these conditions: Rectal Cancer or anal carcinoma or Anal Cancer?
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
Clear my responses

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