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Topical or Ablative Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Squamous Intraepithelial Lesions (ANCHOR)

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ClinicalTrials.gov Identifier: NCT02135419
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : September 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This randomized phase III trial compares 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. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer.

Condition or disease Intervention/treatment Phase
Anal Cancer High-grade Squamous Intraepithelial Lesion HIV Infection Human Papilloma Virus Infection Drug: imiquimod Drug: fluorouracil Procedure: infrared photocoagulation therapy Procedure: thermal ablation therapy Procedure: laser therapy Other: clinical observation Other: laboratory biomarker analysis Procedure: quality-of-life assessment Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5058 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study
Study Start Date : September 24, 2014
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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 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.
Drug: imiquimod
Applied topically
Other Names:
  • Aldara
  • IMQ
  • R 837
Drug: fluorouracil
Applied topically
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
Procedure: infrared photocoagulation therapy
Undergo infrared coagulation
Other Names:
  • infrared coagulation
  • IRC
Procedure: thermal ablation therapy
Undergo hyfrecation/electrocautery therapy
Procedure: laser therapy
Undergo laser therapy
Other Name: therapy, laser
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Active Comparator: Arm II (active monitoring)
Patients undergo active monitoring with examinations every 6 months. Every 12 months, patients undergo biopsies of visible lesions. Patients have cytology sampling performed at every visit.
Other: clinical observation
Undergo active monitoring
Other Name: observation
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Outcome Measures

Primary Outcome Measures :
  1. Time to anal cancer [ Time Frame: Time from randomization to diagnosis of anal cancer, assessed up to 5 years ]
    The log-rank test will be used to compare the treatment and control arms with respect to time to detection of anal cancer. For each arm, the hazard rate and its 95% confidence interval will be estimated. The proportional hazards model will be used to assess the association of study site, lesion size, lesion location, nadir CD4 level and gender with time to detection of anal cancer.

Secondary Outcome Measures :
  1. Incidence of adverse events for each treatment [ Time Frame: Up to 5 years ]
    Summarized by type of adverse event and severity grade for each of the treatments. For adverse events that occur in more than 5% of any of the treatments, the Poisson rates will be used to estimate the number of adverse events per unit time and the binomial proportion and its 95% confidence interval will be used to estimate the proportion of participants who reported the event.

  2. Quality of life assessed using the Functional Assessment of Incontinence Therapy - Fecal (FAIT-F) questionnaire [ Time Frame: Up to 5 years ]
    Descriptive statistics will be used for subscales and scores for each arm and each time point. General estimating equations will be used to compare the two arms with respect to subscales and scores across time points and adjustment for intra-participant variability.

Other Outcome Measures:
  1. Viral factors in HSIL progression to cancer [ Time Frame: Up to 5 years ]
    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.

  2. Host factors in HSIL progression to cancer [ Time Frame: Up to 5 years ]
    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.

  3. Host and viral biomarkers of progression from HSIL to cancer [ Time Frame: Up to 5 years ]
  4. Behavioral risk factors for HSIL progression to cancer [ Time Frame: Up to 5 years ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-1 infection, as documented by any federally approved, licensed HIV test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests; an approved antibody test will be used to confirm diagnosis; if the physician is treating a patient with combination antiretroviral therapy (cART) with a history of HIV positivity based on an approved antibody test then repeat antibody confirmation is not necessary
  • No history of treatment or removal of HSIL
  • No history of anal cancer or signs of anal cancer at baseline, and no history of penile, vulvar, vaginal or cervical cancer
  • 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, cervical cytology (if having a cervix) and gynecologic evaluation including vulvar examination 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), 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 in this study; men who could father a child should use at least two forms of birth control for 3 months after stopping all study 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 within the 4 weeks before randomization enrollment, other than investigational antiretroviral agents for HIV
  • History of anal cancer, penile, vulvar, vaginal or cervical cancer
  • History of prior treatment or removal of anal HSIL
  • 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
  • History of HPV vaccination, or intention to receive an HPV vaccine during study participation
  • Prior pelvic radiation therapy that would preclude radiation therapy if anal cancer develops
  • 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 during study participation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135419

Contact: Abigail Arons, MPH 844-448-2888 abigail.arons@ucsf.edu

United States, California
UCLA CARE Clinic Recruiting
Los Angeles, California, United States, 90035
Contact: Faith Landsman    310-557-3743    flandsman@mednet.ucla.edu   
Principal Investigator: Ronald Mitsuyasu, MD         
UCLA School of Nursing Recruiting
Los Angeles, California, United States, 90095
Contact: Dorothy Wiley, PhD    310-825-0540    dwiley@ucla.edu   
Principal Investigator: Ronald Mitsuyasu, MD         
Sub-Investigator: Ardis Moe, MD         
University of California at San Francisco Anal Dysplasia Clinic Recruiting
San Francisco, California, United States, 94115
Contact: Rachel Silverstein    415-353-7443    rachel.silverstein@ucsf.edu   
Principal Investigator: Joel Palefsky, MD         
Sub-Investigator: J. Michael Berry-Lawhorn, MD         
Sub-Investigator: Naomi Jay, RN, NP, PhD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: M. Ray, MSN    303-724-0712    graham.ray@ucdenver.edu   
Principal Investigator: Thomas Campbell, MD         
Sub-Investigator: Hillary Dunlevy, MD         
Denver Public Health Recruiting
Denver, Colorado, United States, 80204
Contact: Jim Scott    303-602-8741    james.scott@dhha.org   
Principal Investigator: Edward Gardener, MD         
United States, District of Columbia
Capital Digestive Care Recruiting
Washington, D.C., District of Columbia, United States, 20006
Contact: Jessica Korman    240-737-0085    anchor@capitaldigestivecare.com   
Principal Investigator: Jessica Korman, MD         
Dupont Circle Physicians Group Recruiting
Washington, D.C., District of Columbia, United States, 20009
Contact: Benjamin Stearn, MD    202-745-0201    anchor@dupontdocs.com   
Principal Investigator: Benjamin Stearn, MD         
United States, Florida
ACC Clinic, Jackson Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Isabella Rosa-Cunha    305-243-4598    irosa-cunha@med.miami.edu   
Principal Investigator: Isabella Rosa-Cunha, MD         
University of Miami Miller School of Medicine - Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Isabella Rosa-Cunha    305-213-4713    isrosa-cunha@med.miami.edu   
Principal Investigator: Isabella Rosa-Cunha, MD         
United States, Illinois
Anal Dysplasia Clinic MidWest Recruiting
Chicago, Illinois, United States, 60614
Contact: Gary Bucher, MD    312-623-2625    garybuchermd@comcast.net   
Principal Investigator: Gary Bucher, MD         
United States, Louisiana
CrescentCare Health Recruiting
New Orleans, Louisiana, United States, 70119
Contact: Christiane Geisler    504-293-6878    Christiane.geisler@crescentcarehealth.org   
Principal Investigator: Toby Fugate, DO         
Sub-Investigator: Michael Hagensee, PhD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Elizabeth Stier, MD    617-414-5149    elizabeth.stier@bmc.org   
Principal Investigator: Elizabeth Stier, MD         
Fenway Health Terminated
Boston, Massachusetts, United States, 02215
United States, New York
Cornell Clinical Trials Unit, Chelsea Center Recruiting
New York, New York, United States, 10010
Contact: Christina Megill    212-746-7163    chm2029@med.cornell.edu   
Principal Investigator: Timothy Wilkin, MD, MPH         
Laser Surgery Care Recruiting
New York, New York, United States, 10011
Contact: Stephen Goldstone    212-242-6500    drgoldstone@lasersurgerycare.com   
Principal Investigator: Stephen Goldstone, MD         
Montefiore - Albert Einstein College of Medicine Recruiting
The Bronx, New York, United States, 10461
Contact: Zachary Thorogood    718-920-6680    zthorogo@montefiore.org   
Principal Investigator: Rebecca Levine, MD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jin Zhang    336-716-4267    jinzhang@wakehealth.edu   
Principal Investigator: Luis Barroso, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Angie Woodstock    206-342-6539    angela.woodstock@virginiamason.org   
Principal Investigator: David Aboulafia, MD         
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Lindsay Legg    206-744-8748    lmlegg@u.washington.edu   
Principal Investigator: Robert Harrington         
The Polyclinic Recruiting
Seattle, Washington, United States, 98104
Contact: Gary Brown    206-860-4761    gary.brown@polyclinic.com   
Principal Investigator: Juan De La Ossa, MD         
Puerto Rico
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00936
Contact: Maribel Tirado-Gomez    787-772-8300    maribel.tirado1@upr.edu   
Principal Investigator: Maribel Tirado-Gomez, MD         
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
University of Arkansas
University of California, San Francisco
Principal Investigator: Joel Palefsky, MD AIDS Malignancy Consortium
More Information

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT02135419     History of Changes
Other Study ID Numbers: AMC-A01
NCI-2014-00636 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AMC-A01 ( Other Identifier: AIDS - Associated Malignancies Clinical Trials Consortium )
AMC-A01 ( Other Identifier: CTEP )
U01CA121947 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Virus Diseases
Anus Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases