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Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men

18 Years
85 Years
Not Enrolling
Anal Cancer

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Trial Information

Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men

200 subjects will be selected out of a pool of MSM patients in Dr. Stephen Goldstone's
private medical practice, Laser Surgery Care, who have in the past and/or are currently
being screened for anal dysplasia.

Subjects who come into the office for a follow-up appointment for anal condyloma and/or anal
dysplasia treatment will be asked to participate in the study. If written consent is
provided, subjects will be asked to complete a written questionnaire.

Subjects will also be selected out of a pool of patients who have been lost to follow-up,
defined as having failed to come in for a follow-up visit > 12 months after their last
appointment for treatment or screening for anal condyloma and/or anal dysplasia. These
subjects will be contacted via telephone and asked to participate in a brief telephone
interview (approximately 14 minutes in duration). The interview is identical to the written
questionnaire. At the conclusion of the interview, subjects will be given the opportunity
to schedule a follow-up appointment.

Medical records for all subjects who agree to participate in the study will be used to
confirm screening visit history as well as history and severity of dysplasia. In addition,
HIV status will also be confirmed by review of the medical chart. Data will be entered into
an anonymous medical record summary sheet. Information will then be entered into an
electronic database identified only by subject number.

Subjects will be divided into cohorts based on follow-up care seeking behavior: 1) those who
come in for regular screening defined as at least once per year, 2) those who came in once
and were lost to follow-up, 3) those who came in for more than one screening visit and were
then lost to follow-up, and 4) those who were previously lost to follow-up and then began
coming in for screening again. Questionnaire responses will be compared across cohorts to
determine which variables differ significantly. t-Tests, one way, and multivariate analysis
of variance, and correlation analysis will be used as indicated by variable type.

Patients will not receive any compensation for their participation in the study.

Inclusion Criteria:

- MSM patients in Dr. Stephen Goldstone's private surgical practice who previously
tested positive for one of the known HPV subtypes (HPV types 6, 11, 16, 18, 31, 33
and 35) and developed condyloma and/or dysplasia in the anogenital region.

Exclusion Criteria:

- Failure to provide consent to participate in the telephone or written questionnaire.

- Development of anal cancer.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Stephen E. Goldstone, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

May 2008

Related Keywords:

  • Anal Cancer
  • Condyloma Accuminata
  • Low Grade Squamous Intraepithelial Lesion
  • High Grade Squamous Intraepithelial Lesion
  • Anal Cancer Screening
  • Anus Neoplasms



Laser Surgery Care New York, New York  10011