Anal Cancer Screening Study
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|ClinicalTrials.gov Identifier: NCT00914537|
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : April 5, 2018
|First Submitted Date||June 4, 2009|
|First Posted Date||June 5, 2009|
|Last Update Posted Date||April 5, 2018|
|Study Start Date||June 2, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||High resolution anoscopy [ Time Frame: 1 to 2 years ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00914537 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Natural History of Anal HPV in HIV-positive men|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Anal Cancer Screening Study|
|Official Title||Anal Cancer Screening Study|
- To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive men who have sex with men.
- HIV-positive MSM that are interested in receiving anal screening for precancer
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.
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.
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.
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 Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
|Ages||18 Years to 110 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999909158
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 21, 2017|