Welcome

The ANCHOR study is a collaboration of the AIDS Malignancy Consortium's Human Papillomavirus Working Group and the University of California San Francisco, and is sponsored by the National Cancer Institute's Office of HIV and AIDS and Malignancy (OHAM). The ANCHOR (Anal HSIL/Cancer Outcomes Research Study planned to enroll 5,058 participants, both men and women, age 35 and older who have HIV infection and biopsy-proven high-grade squamous intraepithelial lesions (HSIL) at baseline. Eligible participants will have no history of anal cancer, or treatment or removal of HSIL within 6 months before randomization. Eligible participants will be randomized to treatment or active monitoring at baseline. Participants will be followed every six months for HSIL outcomes for at least five years after the last participant is randomized. Throughout the study, the incidence of invasive cancer in both arms will be monitored, and biospecimens and associated participant data will be collected for correlative science studies.

The ANCHOR study closed to enrollment as of September 23, 2021, following the DSMB's determination that the study had met its primary endpoint early. Study results have been published in the New England Journal of MedicineThe results showed that treatment of anal HSIL was successful in reducing the risk of anal cancer compared with active monitoring without treatment. Based on this, the study is offering treatment and/or follow-up after treatment for people who were in the active monitoring arm. We are also offering continued treatment and/or follow-up after treatment to everyone who was in the treatment arm. If participants do not choose to be treated, they may also remain in the study to continue routine monitoring of anal HSIL. The study will conclude all treatment and follow-up on September 30, 2024. 

FOR STUDY PARTICIPANTS

If you are a participant in the ANCHOR study and need to contact the site where you are enrolled, please visit the ANCHOR Study website at https://anchorstudy.org/ and click on "Find your study site" to reach your study team, or call 1-844-448-2888 to reach a member of the National Recruitment team at UCSF.

For additional study information, visit ClinicalTrials.gov at https://clinicaltrials.gov/ct2/show/NCT02135419.

FOR STUDY SITES ONLY

The ANCHOR Data Management Center (DMC) website is intended for study operations resources for participating ANCHOR sites, ANCHOR committee members, and ANCHOR support staff. Content includes study documents, data reports, announcements, calendar of study activities, rosters, meeting-related materials, as well as serving as the gateway to the AdvantageEDC/Advantage eClinical and ePRO training and production systems for study data entry.  The operations website is maintained by the ANCHOR DMC and is distinct from the ANCHOR public website, www.anchorstudy.org, which is maintained by the University of California, San Francisco and the ANCHOR Recruitment and Retention Committee.  As a live website for study communications, website content will be updated regularly.

Questions regarding the use of this website may be directed to the ANCHOR DMC via email at anchordmc@emmes.com.

Please use the following group e-mails and contacts to direct study communications to the appropriate stakeholders:

  • ANCHOR DMC Data Hotline, 1-844-200-8951: Reaches the ANCHOR DMC for urgent data systems issues. All issues that do not require immediate action may be redirected to anchordmc@emmes.com or the appropriate ANCHOR group email address. Clinical issues must be directed to the protocol team.
  • anchorDMC@emmes.com: Reaches the ANCHOR DMC for questions regarding data systems, monitoring, AEs, MOP, website, staff changes, study documents, participant transfers, or HRA/treatment certification documentation
  • anchor-bio@emmes.com: Reaches the ANCHOR Biorepository and DMC for questions regarding all specimen and biorepository items
  • anchor-prot@emmes.com: Reaches the protocol team for protocol interpretation and clinical questions, cases of anal cancer or suspicion for cancer
  • anchor-reg@emmes.com: Reaches members of the ANCHOR DMC for regulatory document submission
  • anchor-rrc@emmes.com: Reaches members of the National Recruitment team at UCSF for discussion of recruitment and retention plans, support for recruitment materials and strategies, and queries regarding the ANCHOR hotline, 1-844-448-2888, and the external study website, www.anchorstudy.org.
  • anchor-QA@emmes.com: Reaches the QA committee for questions and document submission regarding HRA and HSIL treatment certification, source documents, clinical quality issues, and drop-ins to treatment
  • cancer-sae@emmes.com: Reaches the ANCHOR medical monitor for support with adverse event reporting and study safety issues.
  • ANCHORfinance@emmes.com: Reaches Emmes's Finance Department for AMC reimbursement forms, process, any ClinCard issues, or study expenses incurred beginning September 1, 2020.
  • anchorclincard@emmes.com: Reaches members of the ANCHOR DMC for all ClinCard related inquiries or requests, adding/removing staff members to ClinCard or ordering ClinCards.