Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV

Jeannette Y Lee; Shelly Y Lensing; J Michael Berry-Lawhorn; Naomi Jay; Teresa M Darragh; Stephen E Goldstone; Timothy J Wilkin; Elizabeth A Stier; Mark Einstein; Julia C Pugliese; Joel M Palefsky; ANCHOR Investigators

doi:10.1016/j.cct.2022.106679

Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV

Contemp Clin Trials. 2022 Feb:113:106679. doi: 10.1016/j.cct.2022.106679. Epub 2022 Jan 10.

Affiliations

¹ University of Arkansas for Medical Sciences, 4301 West Markham, Slot #781, Little Rock, AR 72205, USA. Electronic address: JYLee@uams.edu.
² University of Arkansas for Medical Sciences, 4301 West Markham, Slot #781, Little Rock, AR 72205, USA. Electronic address: sylensing@uams.edu.
³ University of California, San Francisco, Hematology Oncology, 1600 Divisadero Street, Room A641, Box 1699, San Francisco, CA 94143, USA. Electronic address: jmichael.berry@ucsf.edu.
⁴ University of California, San Francisco, Mt. Zion Medical Center, 1701 Divisadero Street, Suite 480, Box 1217, San Francisco, CA 94143, USA. Electronic address: naomi.jay@ucsf.edu.
⁵ University of California, San Francisco, Mt. Zion Medical Center Depts. of Pathology, OB/Gyn Box 1785, 1600 Divisadero Street, Room B618, San Francisco, CA 94143, USA. Electronic address: teresa.darragh@ucsf.edu.
⁶ Laser Surgery Care Center, 420 West 23rd Street, Suite PB, New York, NY 10011, USA.
⁷ Weill Medical College of Cornell University, Cornell Clinical Trials Unit, 53 West 23rd Street, 6th Floor, New York, NY 10010, USA. Electronic address: tiw@med.cornell.edu.
⁸ Boston Medical Center, Department of Obstetrics and Gynecology, 85 E. Concord Street, 6th Floor, Boston, MA 02118, USA. Electronic address: elstier@bu.edu.
⁹ Rutgers New Jersey Medical School, Medical Science Building (MSB), 185 South Orange Avenue, Room E-506, Newark, NJ 07101, USA. Electronic address: me399@njms.rutgers.edu.
¹⁰ Emmes Company, LLC, 401 N. Washington Street, Rockville, MD 20850, USA. Electronic address: jpugliese@emmes.com.
¹¹ University of California, San Francisco, 513 Parnassus Ave, Room S420, Box 0654, San Francisco, CA 94143, USA. Electronic address: joel.palefsky@ucsf.edu.

Abstract

It is well established that persons living with HIV (PLWH) have highly elevated rates of anal HSIL and anal cancer compared with those who are not living with HIV. The 5-year risk of anal cancer following anal HSIL has been reported to be as high as 14.1% among PLWH compared with 3.2% among those who are not living with HIV. To address these concerns, the AIDS Malignancy Consortium completed a large-scale, randomized trial to compare strategies for the prevention of anal cancer among PLWH with anal HSIL. The objective of the study was to determine whether treating anal HSIL was effective in reducing the incidence of anal cancer in PLWH compared with active monitoring. This paper describes the design of the ANal Cancer/HSIL Outcomes Research Study (ANCHOR) with respect to estimating the anal cancer event rate in this high risk population.

Keywords: Anal cancer prevention; Clinical trial design; Persons living with HIV.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural

MeSH terms

Anus Neoplasms* / epidemiology
Anus Neoplasms* / pathology
Anus Neoplasms* / prevention & control
HIV Infections* / complications
HIV Infections* / epidemiology
Humans
Outcome Assessment, Health Care
Papillomavirus Infections* / epidemiology
Risk Factors
Surveys and Questionnaires

Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV

Authors

Affiliations

Abstract

Publication types

MeSH terms

Grants and funding