Anal Cancer Screening Study

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Brief Title

Anal Cancer Screening Study

Official Title

Anal Cancer Screening Study

Brief Summary

      Background:

        -  HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach
           those of cervical cancer in women. However, unlike cervical cancer, there is no current
           recommended method of screening that could be used to detect anal precancerous lesions
           for the prevention of anal cancer in HIV-positive MSM.

        -  Infections by human papillomavirus (HPV) are the likely cause of cervical and anal
           precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to
           identify women who may be at increased risk of cervical cancer; researchers believe that
           early detection of HPV or related biomarkers in MSM may be useful for anal cancer
           screening.

      Objectives:

      - To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive
      men who have sex with men.

      Eligibility:

      - HIV-positive MSM that are interested in receiving anal screening for precancer

      Design:

        -  HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will
           undergo a physical exam and a high-resolution anoscopy at the participating clinic.

        -  The clinician will then collect to anal Pap specimens from each subject for research on
           HPV and related biomarkers.

        -  Participants will be followed annually for 2 years to collect additional health data for
           research follow-up.
    

Detailed Description

      BACKGROUND:

      Human immunodeficiency virus (HIV) positive men who have sex with men (MSM) are at risk of
      anal cancer that approaches the risk of cervical cancer for unscreened women living in
      developing countries. There is currently no accepted method for screening HIV positive MSM
      for anal precancer to reduce the morbidity and mortality due to anal cancer ; in the absence
      of a standard and effective screening modality, clinics often resort to anoscopy, a
      diagnostic procedure akin to colposcopy, and directed biopsies on all HIV positive MSM.

      OBJECTIVE:

      Evaluate the clinical performance of detecting carcinogenic human papillomavirus (HPV) DNA
      and RNA, individual carcinogenic HPV genotypes, cytogenetic markers, p16(INK4a) and Ki-67
      immunocytochemistry staining, anal cytology, and combinations of these biomarkers for
      identifying HIV positive MSM with prevalent, 1 year cumulative, and 2 year cumulative anal
      precancer and cancer (histologically-confirmed greater than or equal to AIN3) using
      clinician-collected anal specimens at baseline.

      ELIGIBILITY:

      HIV positive MSM seeking anal cancer screening. Inclusion: 1) KPNC member; 2) documented
      HIV-positive status; 3) able and mentally competent to provide written, informed consent.
      Exclusion:A current diagnosis of anal cancer at enrollment.

      DESIGN:

      To address this need and to improve detection of anal precancer and cancer, we propose a
      screening cohort study of 1,000 HIV positive MSM participating in the Kaiser Permanente
      Northern California (KPNC) health maintenance program. Under written, informed consent,
      participating KPNC members will respond to a self-administered risk factor questionnaire and
      will undergo two anal specimen collections into liquid-based cytology (LBC) medium prior to a
      digital exam and high resolution anoscopy. Subjects will be asked to self-collect at home
      into the same LBC buffer and return their specimen in a prepared return envelope to evaluate
      the utility of self-collection for anal cancer screening. Subjects will be followed annually
      for two years to collect follow-up clinical data related to outcomes. Baseline
      clinician-collected specimens will be tested in a masked fashion for the following clinical
      biomarkers: 1) carcinogenic HPV DNA in aggregate and individual carcinogenic HPV genotypes;
      2) carcinogenetic HPV RNA and HPV16/18 RNA; 3) cytogentic changes (3q, 5p, and 20q
      amplification); and 4) p16(INK4a) and Ki-67 immunocytochemical staining. For reference,
      clinician-collected specimens will be used to make LBC slides and evaluated by an expert
      cytopathology laboratory. We will estimate the clinical performance (sensitivity,
      specificity, positive and negative predictive values, and referral rates) for detection of
      prevalently-detected, one-year cumulative, and two-year cumulative histologically-confirmed
      anal precancer (anal intraepithelial neoplasia grade 3) or worse (greater than or equal to
      AIN3). We will test the self-collected anal specimens by the best molecular test(s) or
      combination of tests for detection of prevalently-detected greater than or equal to AIN3 as
      determined from testing the clinician-collected specimens. All MSM will undergo diagnostic
      procedures at all visits and independent of testing results, which will result in unbiased
      disease ascertainment.
    


Study Type

Observational


Primary Outcome

High resolution anoscopy


Condition

Anal Cancer


Study Arms / Comparison Groups

 1
Description:  Human immunodeficiency virus (HIV) positive adult men who have sex with men that are members of KPNC (Kaiser Permanente Northern California) and do not have a current anal cancer diagnosis.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

363

Start Date

June 2, 2009

Completion Date

November 4, 2020

Primary Completion Date

November 4, 2020

Eligibility Criteria

        -  2.1 ELIGIBILITY CRITERIA:

        Any male member of KPNC who is 1) identified as HIV positive through the Kaiser HIV
        registry, 2) 18 years or older, can provide written, informed consent, and 3) is not
        currently diagnosed with anal cancer (prior to enrollment).

        2.2 INCLUSION CRITERIA:

        HIV-positive men will be invited to participate, regardless of race and ethnicity, as
        described below if they meet the eligibility criteria. Other than having been diagnosed
        with anal cancer prior to enrollment, there will no other disease-based exclusions. Because
        of the high fraction of HIV-positive men are in fact MSM, we will not prescreen men for
        their sexual orientation.

        2.3 EXCLUSION CRITERIA:

        The exclusion criteria will be age less than 18, a current diagnosis of anal cancer
        rendered prior to enrollment, an unwillingness or inability (evident mental incapacity to
        understand the informed consent documents) to give informed consent.
      

Gender

Male

Ages

18 Years - 110 Years

Accepts Healthy Volunteers

No

Contacts

Nicolas Wentzensen, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00914537

Organization ID

999909158

Secondary IDs

09-C-N158

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Nicolas Wentzensen, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

October 2020