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Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT00695422
First received: June 7, 2008
Last updated: November 17, 2015
Last verified: November 2015
  Purpose

RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection and squamous intraepithelial lesions and help doctors plan better treatment.

PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.


Condition Intervention
Aids-related Malignancies
Lymphoma
Precancerous Condition
Sarcoma
Genetic: polymerase chain reaction
Other: cytology specimen collection procedure
Other: histological technique
Procedure: colposcopic biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Consortium:

Primary Outcome Measures:
  • Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL) [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ] [ Designated as safety issue: No ]
  • Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ] [ Designated as safety issue: No ]
  • Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ] [ Designated as safety issue: No ]
  • Changes in anal HPV types present [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ] [ Designated as safety issue: No ]
  • Frequency of ASIL [ Time Frame: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood specimens, anal cytology and biopsy of any lesions observed, cervical cytology and biopsy of any lesions observed.

Estimated Enrollment: 15
Study Start Date: May 2008
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Specimen Collection
Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
Genetic: polymerase chain reaction
PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
Other: cytology specimen collection procedure
Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
Other: histological technique
Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
Procedure: colposcopic biopsy
Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

Detailed Description:

OBJECTIVES:

Primary

  • To determine if various pharmacotherapeutic agents investigated in primary AIDS Malignancy Clinical Trials (AMC) for diseases other than human papillomavirus (HPV)-associated neoplasia have any preliminary evidence of activity against anogenital HPV infection or anogenital squamous intraepithelial lesions (ASIL) in HIV-positive patients participating in these trials.
  • To describe changes in the types of anal HPV present and the prevalence of ASIL in patients treated on these studies.
  • To evaluate cervical HPV infection and cervical/vulvovaginal disease in HIV-positive women participating in these trials.
  • To describe changes in cervical HPV infection and cervical/vulvovaginal disease in these women after undergoing various study treatments.

OUTLINE: This is a multicenter study.

Patients undergo anal swab collection at baseline to obtain samples for anal cytology, anal human papillomavirus (HPV) typing, and other HPV-related testing (e.g., HPV viral load). Digital rectal examinations (DRE) are also performed as part of the baseline physical examination. Female patients also undergo cervical swab collection for cervical HPV testing and cytology, as well as colposcopy (if available) of the cervix and vulvovaginal region to completely assess lower genital tract HPV-related lesions. At sites where high-resolution anoscopy (HRA) is available, patients are encouraged, but not required, to have an HRA with biopsy of any visualized lesions within 30 days of collection of the swabs.

After baseline assessments, patients undergo treatment with the investigative agent according to the study protocol requirements. If study treatment continues beyond 6 months, additional anal and cervical swabs are obtained for anal and cervical HPV and cytology along with DREs every 6 months until completion of study treatment and at the final study visit. Patients may also undergo additional HRA with biopsy and/or colposcopy of the lower genital tract with biopsy (women only) at this time. Patients with an abnormal anal cytology or histology are referred for HRA per local standard of care. If HRA is not available at the treatment site, patients undergo a DRE, and those with an abnormal DRE are referred for evaluation by a surgeon.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll patients who are study participants on interventional AMC protocols for diseases other than HPV-associated neoplasia with an accrual goal of 15 patients or more.
Criteria

DISEASE CHARACTERISTICS:

  • Serologic documentation of HIV infection by any FDA-approved tests
  • Enrolled in an AIDS Malignancy Clinical Trials Consortium (AMC) clinical trial of any new or existing pharmacotherapeutic agent for treatment of disease other than human papillomavirus (HPV)-associated neoplasia

    • AMC study must have an accrual target of > 15 patients

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • Life expectancy ≥ 3 months
  • Not pregnant or nursing
  • Patients receiving myelosuppressive therapy must meet the following criteria:

    • ANC > 1,000/μL
    • Platelet count > 50,000/μL
    • Evaluated before treatment or completely recovered from their nadir
  • Able to understand and willing to sign a written informed consent document
  • No bleeding disorder or requirement for anticoagulation that would contraindicate any biopsy of the anal canal

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695422

Locations
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90095-1793
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2707
United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
Investigators
Principal Investigator: J. Michael Berry, MD University of California, San Francisco
  More Information

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00695422     History of Changes
Other Study ID Numbers: AMC-058  U01CA121947  CDR0000590397 
Study First Received: June 7, 2008
Last Updated: November 17, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by AIDS Malignancy Consortium:
high-grade squamous intraepithelial lesion
low-grade squamous intraepithelial lesion
human papilloma virus infection
AIDS-related diffuse large cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related Kaposi sarcoma
AIDS-related lymphoblastic lymphoma
AIDS-related malignancies
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
AIDS-related small noncleaved cell lymphoma
multicentric Castleman disease
HIV Infections

Additional relevant MeSH terms:
Infection
Lymphoma
Neoplasms
Sarcoma
Precancerous Conditions
Papillomavirus Infections
Squamous Intraepithelial Lesions of the Cervix
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Uterine Cervical Dysplasia
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 23, 2016