Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
NCT ID: NCT02135419
Last Updated: 2024-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4446 participants
INTERVENTIONAL
2014-09-24
2024-03-31
Brief Summary
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The ANCHOR Data Safety Monitoring Board (DSMB) determined that the primary study endpoint was completed, based on the data and statistical analysis presented to them on 07SEP2021.
In the post-randomization phase of this trial, all enrolled participants are offered treatment for HSIL and/or follow-up, at the participant's choice.
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Detailed Description
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I. To determine the effectiveness of treating anal HSIL to reduce the incidence of anal cancer in human immunodeficiency virus (HIV)-infected men and women.
SECONDARY OBJECTIVES:
I. To determine the safety of infrared coagulation (IRC), electrocautery, imiquimod, laser and 5- fluorouracil treatments for anal HSIL.
II. To assess the responsiveness (sensitivity to change) and clinical significance of the ANCHOR Health-Related Symptom Index (A-HRSI) subscales by comparing change scores within groups of participants as defined by participant responses to the participant global impression of change (PGIC) item. (completed FEB2020)
TERTIARY OBJECTIVES:
Collect clinical specimens and data to create a bank of well-annotated specimens that will enable correlative science:
I. Identification of viral factors in HSIL progression to cancer; II. Identification of host factors in HSIL progression to cancer; III. Identify host and viral biomarkers of progression from HSIL to cancer; IV. Identify medical history and behavioral risk factors for HSIL progression to cancer.
QUALITY OF LIFE OBJECTIVES (completed FEB2022) I. Primary QOL Objective: To compare arms in terms of changes in physical symptoms and impacts from T2 to T3, adjusting for T1.
ANCILLARY (COVID SUPPLEMENT) SUBSTUDY OBJECTIVES:
I. Determine the prevalence of SARS-CoV-2 detection in anal and oropharyngeal swabs among people living with HIV (PLWH) being screened for and enrolled in the ANCHOR study.
II. Determine the relationship between prevalent anal SARS-CoV-2 positivity, anal HPV infection, and anal high-grade squamous intraepithelial lesions (HSIL).
III. Determine the 6-month incidence of SARS-CoV-2 detection in anal and oropharyngeal swabs among participants in the active monitoring arm being assessed for the first time for treatment and individuals already enrolled in the COVID substudy under protocol version 15.0.
IV. Determine the relationship between prevalent or incident SARS-CoV-2 detection and regression of anal HPV infection or HSIL among active monitoring arm participants already enrolled in the COVID substudy under protocol version 15.0, and those who continue the protocol and who choose not to be treated at visit 101.
OUTLINE: The randomized strategy to study the efficacy of HSIL treatment to reduce the risk of progression to anal cancer, as compared to active monitoring, was discontinued for all participants.
Patients are randomized to 1 of 2 treatment arms. (accrual closed SEP2021)
ARM I: Patients are directed to receive either topical or ablative treatment at the discretion of the clinician. Patients receiving topical treatment apply topical imiquimod intra-anally, peri-anally or both thrice weekly for up to 16 weeks, or topical 5-fluorouracil twice daily for 5 days every 2 weeks for up to 16 weeks. Patients receiving ablative treatment using infrared coagulation, hyfrecation/electrocautery, or laser. Patients may undergo excision under anesthesia if the clinician believes none of the other treatment approaches will be effective. The number and timing of such treatments will be at the discretion of the investigator. Patients with persistent HSIL should continue a protocol-approved treatment or a new protocol treatment should be considered.
ARM II: Patients undergo active monitoring with HRA examinations and anal cytology every 6 months. Every 12 months, patients undergo biopsies of visible lesions.
Participants on both arms are to be followed for up to 5 years after randomization of the last participant.
Post-randomization phase: Individuals in the treatment arm may continue treatment, and participants in the active monitoring arm are offered treatment. If upon assessment participants continue to have HSIL but do not intend to get treatment, they will be monitored for the potential for disease progression to anal cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I (treatment)
Patients are directed to receive either topical or ablative treatment at the discretion of the clinician. Patients receiving topical treatment apply imiquimod intra-anally, peri-anally or both thrice weekly for up to 16 weeks, fluorouracil twice daily for 5 days every 2 weeks for up to 16 weeks, or trichloroacetic acid every 3 weeks up to 12 weeks. Patients receiving ablative treatment using infrared photocoagulation therapy, hyfrecation/electrocautery (thermal ablation therapy), or laser therapy. Patients may undergo excision under anesthesia if the clinician believes none of the other treatment approaches will be effective. The number and timing of such treatments will be at the discretion of the investigator. Patients with persistent HSIL should continue a protocol-approved treatment or a new protocol treatment should be considered. All participants will have samples collected for laboratory biomarker analysis.
imiquimod
Applied topically
fluorouracil
Applied topically
infrared photocoagulation therapy
Undergo infrared coagulation
thermal ablation therapy
Undergo hyfrecation/electrocautery therapy
laser therapy
Undergo laser therapy
clinical observation
Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies
laboratory biomarker analysis
Correlative studies
Arm II (active monitoring) (closed since SEP2021)
Patients undergo active monitoring with examinations for clinical observation every 6 months. Every 12 months, patients undergo biopsies of visible lesions. Patients have cytology sampling performed at every visit. All participants will have samples collected for laboratory biomarker analysis.
clinical observation
Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies
laboratory biomarker analysis
Correlative studies
Interventions
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imiquimod
Applied topically
fluorouracil
Applied topically
infrared photocoagulation therapy
Undergo infrared coagulation
thermal ablation therapy
Undergo hyfrecation/electrocautery therapy
laser therapy
Undergo laser therapy
clinical observation
Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biopsy-proven HSIL at baseline
* At least one focus of HSIL must be identified that is not within a condyloma that may be treated after enrollment into the study
* For females, documentation that the participant is being followed for cervical cytology (if having a cervix) and/or HPV testing per current ASCCP guidelines, and visual examination of the vulva, vagina, and cervix to rule out cancer/suspicion for cancer within 12 months prior to enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 1 (Karnofsky \>= 70%)
* Life expectancy of greater than 5 years
* Absolute neutrophil count: \>= 750/mm\^3
* Platelets: \>= 75,000/mm\^3
* Hemoglobin \>= 9.0 g/dL
* Women of childbearing potential must have a negative urine pregnancy test within 7 days of initiating study treatment if they have been randomized to the treatment arm; all women of childbearing potential must agree to use a reliable birth control method (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued; all participants must be willing to comply with an acceptable birth control regimen as determined by the Investigator
* Men randomized to the treatment arm should not father a baby while receiving topical treatment during this study. Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment.
* Ability to understand and the willingness to sign a written informed consent document
* Participant is willing to be randomized and able to comply with the protocol
* Clinician is comfortable with either following patient for up to 5 years without therapy or treating patient for up to 5 years
Exclusion Criteria
* Patients who are receiving any other immunomodulatory investigational agents (replacement doses of steroids for adrenal insufficiency or treatment with prednisone ≤5 mg/day is permitted) within the 4 weeks before randomization enrollment, other than investigational antiretroviral agents for HIV, or investigational or approved agents for Hepatitis C.
* History of anal cancer, penile, vulvar, vaginal or cervical cancer, or signs of these cancers at baseline.
* Treatment or removal of HSIL less than 6 months prior to randomization.
* Participant has symptoms related to HSIL and would benefit more from immediate treatment than from entry into the study and potential for randomization to active monitoring arm
* Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL
* Participants who only have a single HSIL lesion that is likely to be removed entirely with the initial screening biopsy
* Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
* Participant plans to relocate away from the study site to a location without an ANCHOR study site during study participation
35 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
University of Arkansas
OTHER
University of California, San Francisco
OTHER
University of Arizona
OTHER
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Joel Palefsky, MD
Role: PRINCIPAL_INVESTIGATOR
AIDS Malignancy Consortium
Locations
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UCLA CARE Clinic
Los Angeles, California, United States
UCLA School of Nursing
Los Angeles, California, United States
DAP Health
Palm Springs, California, United States
University of California at San Francisco Anal Dysplasia Clinic
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Public Health
Denver, Colorado, United States
Capital Digestive Care
Washington D.C., District of Columbia, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
ACC Clinic, Jackson Hospital
Miami, Florida, United States
University of Miami Miller School of Medicine - Sylvester Cancer Center
Miami, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Anal Dysplasia Clinic MidWest
Chicago, Illinois, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
CrescentCare Health
New Orleans, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Fenway Health
Boston, Massachusetts, United States
Rutgers University New Jersey Medical School
Newark, New Jersey, United States
Cornell Clinical Trials Unit, Chelsea Center
New York, New York, United States
Laser Surgery Care
New York, New York, United States
Montefiore - Albert Einstein College of Medicine
The Bronx, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
The Polyclinic
Seattle, Washington, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Lee JY, Lensing SY, Berry-Lawhorn JM, Jay N, Darragh TM, Goldstone SE, Wilkin TJ, Stier EA, Einstein M, Pugliese JC, Palefsky JM; ANCHOR Investigators. 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.
Palefsky JM, Lee JY, Jay N, Goldstone SE, Darragh TM, Dunlevy HA, Rosa-Cunha I, Arons A, Pugliese JC, Vena D, Sparano JA, Wilkin TJ, Bucher G, Stier EA, Tirado Gomez M, Flowers L, Barroso LF, Mitsuyasu RT, Lensing SY, Logan J, Aboulafia DM, Schouten JT, de la Ossa J, Levine R, Korman JD, Hagensee M, Atkinson TM, Einstein MH, Cracchiolo BM, Wiley D, Ellsworth GB, Brickman C, Berry-Lawhorn JM; ANCHOR Investigators Group. Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer. N Engl J Med. 2022 Jun 16;386(24):2273-2282. doi: 10.1056/NEJMoa2201048.
Barroso LF, Stier EA, Hillman R, Palefsky J. Anal Cancer Screening and Prevention: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infection Guidelines. Clin Infect Dis. 2022 Apr 13;74(Suppl_2):S179-S192. doi: 10.1093/cid/ciac044.
Higashi RT, Rodriguez SA, Betts AC, Tiro JA, Luque AE, Rivera R, Barnes A. Anal cancer screening among women with HIV: provider experiences and system-level challenges. AIDS Care. 2022 Feb;34(2):220-226. doi: 10.1080/09540121.2021.1883512. Epub 2021 Feb 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2014-00636
Identifier Type: REGISTRY
Identifier Source: secondary_id
AMC-A01
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-A01
Identifier Type: OTHER
Identifier Source: secondary_id
ANCHOR
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-A01
Identifier Type: -
Identifier Source: org_study_id
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