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Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions (ANCHOR)

Primary Purpose

Anal Cancer, High-grade Squamous Intraepithelial Lesion, HIV Infection

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

imiquimod

fluorouracil

infrared photocoagulation therapy

thermal ablation therapy

laser therapy

clinical observation

laboratory biomarker analysis

About this trial

This is an interventional prevention trial for Anal Cancer focused on measuring anal cancer, high-grade squamous intraepithelial lesion, anal HSIL, HIV, HIV/AIDS, human papillomavirus, HPV

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HIV positive. Documentation of HIV-1 infection by means of any one of the following: 1) Documentation of HIV diagnosis in the medical record by a licensed health care provider; 2) Documentation of receipt of ART by a licensed health care provider (receipt of at least two agents is required); 3) HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL; or, 4) Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
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:

Inability to provide informed consent
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

Sites / Locations

UCLA CARE Clinic
UCLA School of Nursing
DAP Health
University of California at San Francisco Anal Dysplasia Clinic
University of Colorado Hospital
Denver Public Health
Capital Digestive Care
Dupont Circle Physicians Group
ACC Clinic, Jackson Hospital
University of Miami Miller School of Medicine - Sylvester Cancer Center
Grady Health System
Anal Dysplasia Clinic MidWest
University Medical Center New Orleans
CrescentCare Health
Boston Medical Center
Fenway Health
Rutgers University New Jersey Medical School
Montefiore - Albert Einstein College of Medicine
Cornell Clinical Trials Unit, Chelsea Center
Laser Surgery Care
Wake Forest Baptist Health
Virginia Mason Medical Center
Harborview Medical Center
The Polyclinic
University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (treatment)

Arm II (active monitoring) (closed since SEP2021)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anal Cancer Incidence

Anal cancer incidence is calculated as the number of anal cancer cases detected per 100,000 person years

Secondary Outcome Measures

Incidence of Adverse Events for Each Treatment

Participants who had at least one adverse event (serious or non-serious)

Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization

The physical symptom score is made up of the sum of responses to whether or not the participant had any of the 9 physical symptoms: anal pain, pain other than anal pain, pain during bowel movements, constipation, bleeding from anus, itching in/around the anus, discharge (wetness) in anal area, burning sensations in the anal area, and urgency for bowel movements. Responses are 0- not at all, 1-a little bit, 2-somewhat, 3-quite a bit, 4-very much. Thus physical symptom score ranges from 0 to 36.

Full Information

NCT ID

NCT02135419

First Posted

May 8, 2014

Last Updated

September 14, 2023

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, University of California, San Francisco, University of Arizona

1. Study Identification

Unique Protocol Identification Number

NCT02135419

Brief Title

Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions

Acronym

ANCHOR

Official Title

ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 24, 2014 (Actual)

Primary Completion Date

August 6, 2021 (Actual)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, University of California, San Francisco, University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. 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.

Detailed Description

PRIMARY OBJECTIVES: The primary objective of this study has been completed for efficacy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Cancer, High-grade Squamous Intraepithelial Lesion, HIV Infection, Human Papilloma Virus Infection

Keywords

anal cancer, high-grade squamous intraepithelial lesion, anal HSIL, HIV, HIV/AIDS, human papillomavirus, HPV

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

All participants are evaluated with high resolution anoscopy and anal cytology every 6 months during study participation. Participants randomized to treatment undergo biopsy of anal HSIL at each 6-month visit, and receive topical or ablative therapies for incident anal HSIL lesions. Active monitoring participants undergo close observation, with biopsy of anal HSIL at annual visits. Participants undergo biopsy of lesions at any time cancer is suspected.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4446 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (treatment)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (active monitoring) (closed since SEP2021)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

imiquimod

Other Intervention Name(s)

Aldara, IMQ, R 837

Intervention Description

Applied topically

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Other Intervention Name(s)

5-fluorouracil, 5-Fluracil, 5-FU, Efudex

Intervention Description

Applied topically

Intervention Type

Device

Intervention Name(s)

infrared photocoagulation therapy

Other Intervention Name(s)

infrared coagulation, IRC

Intervention Description

Undergo infrared coagulation

Intervention Type

Device

Intervention Name(s)

thermal ablation therapy

Intervention Description

Undergo hyfrecation/electrocautery therapy

Intervention Type

Device

Intervention Name(s)

laser therapy

Other Intervention Name(s)

therapy, laser

Intervention Description

Undergo laser therapy

Intervention Type

Other

Intervention Name(s)

clinical observation

Other Intervention Name(s)

observation

Intervention Description

Undergo active monitoring (High Resolution Anoscopy [HRA]) with biopsies

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Anal Cancer Incidence

Description

Anal cancer incidence is calculated as the number of anal cancer cases detected per 100,000 person years

Time Frame

Time from randomization to diagnosis of anal cancer, assessed up to 5 years post randomization

Secondary Outcome Measure Information:

Title

Incidence of Adverse Events for Each Treatment

Description

Participants who had at least one adverse event (serious or non-serious)

Time Frame

Up to 5 years after randomization

Title

Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization

Description

Time Frame

4 weeks post randomization

Other Pre-specified Outcome Measures:

Title

Viral Factors in HSIL Progression to Cancer

Description

Descriptive statistics will be used to describe the integration locus of HPV In the invasive cancers and whether they differ from those of the overlying HSIL. Descriptive statistics will also be used to determine if the loci differ in HSIL that have progressed and concurrent HSIL biopsies that did not progress. In each case only tissues that contain HPV 16 will be analyzed.

Time Frame

Up to 5 years after randomization

Title

Host Factors in HSIL Progression to Cancer

Description

Linear models will be fitted for each gene. Moderated t-statistics, fold-change and the associated p values will be calculated for each gene. Since thousands of genes will be tested, false discovery rate (FDR)-adjusted values will be calculated using the Benjamini-Hochberg method. FDR values indicate the expected fraction of falsely declared differentially expressed (DE) genes among the total set of declared DE genes, i.e. FDR = 0.15 would indicate that 15% of the declared DE genes were expected to be false due to experimental noise instead of actual differential expression.

Time Frame

Up to 5 years after randomization

Title

Host and Viral Biomarkers of Progression From HSIL to Cancer

Description

Biomarkers that are correlated with progression from anal HSIL to anal cancer

Time Frame

Up to 5 years after randomization

Title

Behavioral Risk Factors for HSIL Progression to Cancer

Description

For each risk factor of interest, Fisher's exact test or Pearson's chi-square test will be used to determine if there is an association. Factors associated with invasive anal cancer at the 0.10 significance level will be incorporated into a logistic regression model to determine if they are independently associated with invasive anal cancer. Cox regression analyses will also be used to evaluate the association between risk factors and time to diagnosis of invasive anal cancer.

Time Frame

Up to 5 years after randomization

Title

ANCHOR Study Health-Related Symptom Index (A-HRSI) Scale Responsiveness (Sensitivity to Change)

Description

Participants at follow-up timepoints were categorized into two sets of three groups based on PGIC and ECOG PS responses ("worse," "no change," "better"), with the primary responsiveness analysis using these three groups in a one-way analysis of variance (ANOVA).

Time Frame

A-HRSI and self-reported Patient Global Impression of Change (PGIC) scale and ECOG Performance Status (ECOG PS) item were administered at time of enrollment (T1) up until time of trial randomization (T2), and 71-112 days post-randomization (T3).

Title

Quality of Life Assessment Measured by the A-HRSI (Validated Tool)

Description

A-HRSI physical symptoms and physical impacts subscale change scores (T3 minus T2) using an analysis of covariance adjusting for the covariate baseline (T1) subscale to test for differences between arms at a one-sided 0.025 significance level with approximately 90% power.

Time Frame

A-HRSI completion occurred at 3 time points: Pre-randomization (T1), within 2-7 days (T2) and at 4 weeks of treatment/randomization (T3).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIV positive. Documentation of HIV-1 infection by means of any one of the following: 1) Documentation of HIV diagnosis in the medical record by a licensed health care provider; 2) Documentation of receipt of ART by a licensed health care provider (receipt of at least two agents is required); 3) HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL; or, 4) Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. 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: Inability to provide informed consent 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Palefsky, MD

Organizational Affiliation

AIDS Malignancy Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA CARE Clinic

City

Los Angeles

State/Province

California

ZIP/Postal Code

90035

Country

United States

Facility Name

UCLA School of Nursing

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

DAP Health

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

University of California at San Francisco Anal Dysplasia Clinic

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

University of Colorado Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Denver Public Health

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

Capital Digestive Care

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20006

Country

United States

Facility Name

Dupont Circle Physicians Group

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20009

Country

United States

Facility Name

ACC Clinic, Jackson Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

University of Miami Miller School of Medicine - Sylvester Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Grady Health System

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Anal Dysplasia Clinic MidWest

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

University Medical Center New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

CrescentCare Health

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Fenway Health

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Rutgers University New Jersey Medical School

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

Montefiore - Albert Einstein College of Medicine

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Cornell Clinical Trials Unit, Chelsea Center

City

New York

State/Province

New York

ZIP/Postal Code

10010

Country

United States

Facility Name

Laser Surgery Care

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

The Polyclinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

University of Puerto Rico

City

San Juan

ZIP/Postal Code

00936

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

A CDISC-mapped, de-identified version of the study data with appropriate documentation (data dictionary, annotated static copies of electronic case report forms, clinical protocol, informed consent document) of the data elements will be made available via a public data repository: the AIDS Malignancy Consortium (AMC) Data Commons.

IPD Sharing Time Frame

IPD will only be shared with external investigators following conclusion of all participant data collection and the acceptance of a manuscript(s) that addresses all trial objectives, via release of the data to a public data repository, anticipated to occur on or after August 2025. Data will be available according to the archival terms of the AMC Data Commons.

IPD Sharing Access Criteria

Qualified researchers with plans approved by the AMC Executive Committee who have entered into a Data Use Agreement (DUA) with the AMC will be granted data access. Research plans may include, but are not limited to, research on HIV/AIDS, anal HSIL screening and/or treatment, HPV-associated malignancies, anal cancer, and associated conditions.

Citations:

PubMed Identifier

35017115

Citation

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.

Results Reference

background

PubMed Identifier

35704479

Citation

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.

Results Reference

result

PubMed Identifier

35416975

Citation

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.

Results Reference

derived

PubMed Identifier

33594934

Citation

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.

Results Reference

derived

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Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions

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