NCT00914537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
Last Updated

November 6, 2020

Status Verified

October 1, 2020

Enrollment Period

11.4 years

First QC Date

June 4, 2009

Last Update Submit

November 5, 2020

Conditions

Anal Cancer

Keywords

Anal CancerAINHPVCytologyHIVHIV Positive

Outcome Measures

Primary Outcomes (1)

  • High resolution anoscopy

    Detection of AIN2 and AIN3 in high resolution anoscopy

    1 to 2 years

Study Arms (1)

1

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.

Eligibility Criteria

Age18 Years - 110 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.@@@

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

San Francisco, California, 94115, United States

Location

Related Publications (3)

  • Jemal 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: 18287387BACKGROUND

  • Clark 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: 15003197BACKGROUND

  • Daling 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: 2821396BACKGROUND

MeSH Terms

Conditions

Anus NeoplasmsHIV Seropositivity

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Nicolas Wentzensen, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

June 2, 2009

Primary Completion

November 4, 2020

Study Completion

November 4, 2020

Last Updated

November 6, 2020

Record last verified: 2020-10

Locations

US(1)