Clinical trial · Observational
Anal Cancer Screening Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 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.
Primary outcomes (1)
- measure
- High resolution anoscopy
- timeFrame
- 1 to 2 years
- description
- Detection of AIN2 and AIN3 in high resolution anoscopy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDJemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. PMID 18287387
- BACKGROUNDClark MA, Hartley A, Geh JI. Cancer of the anal canal. Lancet Oncol. 2004 Mar;5(3):149-57. doi: 10.1016/S1470-2045(04)01410-X. PMID 15003197
- BACKGROUNDDaling JR, Weiss NS, Hislop TG, Maden C, Coates RJ, Sherman KJ, Ashley RL, Beagrie M, Ryan JA, Corey L. Sexual practices, sexually transmitted diseases, and the incidence of anal cancer. N Engl J Med. 1987 Oct 15;317(16):973-7. doi: 10.1056/NEJM198710153171601. PMID 2821396