Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.

Condition or disease	Intervention/treatment
Anal Cancer; Cervical Cancer; Lung Cancer; Lymphoma	Genetic: DNA analysis; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: polymorphism analysis; Other: biologic sample preservation procedure; Other: flow cytometry; Other: laboratory biomarker analysis; Other: medical chart review

Detailed Description:

OBJECTIVES:

• To obtain high-quality, clinically annotated tissue from patients with human immunodeficiency virus (HIV)-1 malignancy.
• To study clinical, genetic, and immunologic parameters that have prognostic significance and/or are involved in the initiation and progression of HIV-1 malignancies, including complete genomic sequence determination of HIV-associated diffuse large B-cell lymphomas, lung cancer, anal cancer, and cervical cancer.

OUTLINE: This is a multicenter study.

Patients undergo tumor, lymph node, bone marrow, or skin biopsy, and peripheral blood mononuclear cells collection. Samples are submitted to the AIDS Malignancy Consortium (AMC) Biorepository and transferred to the AIDS and Cancer Specimen Resource (ACSR). Samples are then analyzed by the Genome Science Center of British Columbia (GSC-BC) and the HIV+ Tumor Molecular Characterization Project (HTMCP) for full genomic sequencing analysis that may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies by flow cytometry, cytogenetics, and molecular studies. Patients' clinical data, demographics, and treatment given are also collected prospectively in order to record treatment outcome and toxicity.

Patients are followed up at 6 months, 1 year, and 2 years for data-reporting purposes.

Study Design

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Study Type :	Observational
Estimated Enrollment :	300 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies
Study Start Date :	July 2012
Estimated Primary Completion Date :	June 2020
Estimated Study Completion Date :	June 2020

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Mutational spectrum of each type of HIV-1 associated malignancy [ Time Frame: Study entry (prior to chemotherapy initiation) ]
   Complete genomic sequencing of HIV-1 associated tumor tissue

Biospecimen Retention:   Samples With DNA

Fresh-frozen tissue, Peripheral blood mononuclear cells

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material

Criteria

DISEASE CHARACTERISTICS:

• Participants must have a diagnosis of a malignancy or clinical findings suggestive of a possible HIV-associated malignancy of one of three types:

  • Diffuse large B-cell lymphoma
  • Non-small cell lung malignancy
  • Cervical cancer

• The presence of any of the following conditions will exclude a participant from study enrollment:

  • Absence of sufficient diagnostic tumor-biopsy tissue material to meet the protocol requirements for baseline specimen submission (minimum specimen size of 10 x 10 x 2 mm); repeat tumor biopsy will not be performed solely to meet the protocol specimen-collection requirements
  • Participants whose biopsies, for the purpose of this protocol, show a diagnosis of anal intraepithelial neoplasia or cervical intraepithelial neoplasia
  • Prior treatment for the study malignancy (including neo-adjuvants), since treatment can affect the mutational spectra of tumors
• HIV infection based on serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other Food and Drug Administration (FDA)-approved (licensed) HIV test; alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests

PATIENT CHARACTERISTICS:

• Participants must be willing and able to sign an IRB-approved informed consent document

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Moores UCSD Cancer Center	Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Moores UCSD Cancer Center 858-822-5354 cancercto@ucsd.edu
Principal Investigator: William Wachsman, MD
UCLA Clinical AIDS Research and Education (CARE) Center	Recruiting
Los Angeles, California, United States, 90095-1793
Contact: Maricela Gonzalez 310-557-3729 mmgonzalez@mednet.ecla.edu
Principal Investigator: Ronald Mitsuyasu, MD
United States, Florida
University of Miami	Recruiting
Miami, Florida, United States, 33136
Contact: Juan Carlos Ramos, MD 305-243-6611
Principal Investigator: Juan Carlos Ramos, MD
United States, Hawaii
Cancer Research Center of Hawaii	Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Illinois
John H. Stroger Hospital of Cook County	Recruiting
Chicago, Illinois, United States, 60612
Contact: Paul Rubinstein 312-864-7277
Principal Investigator: Paul Rubinstein, MD
United States, Louisiana
Louisiana State University Public Hospital	Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Eileen Mederos 504-568-3235 emede1@lsuhsc.edu
Principal Investigator: Thomas Reske, MD
United States, Missouri
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lee Ratner, MD, PhD 314-362-8836 lratner@im.wustl.edu
Principal Investigator: Lee Ratner, MD
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine	Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu
Principal Investigator: Missak Haigentz, MD
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Ariela Noy, MD 212-639-7423 noya@mskcc.org
Principal Investigator: Ariela Noy, MD
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center	Recruiting
Chapel Hills, North Carolina, United States, 27599
Contact: Kristy Richards, MD kristy_richards@med.unc.edu
Principal Investigator: Kristy Richards, MD
United States, Pennsylvania
University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Douglas Beach, MD 215-829-6088 douglas.beach@uphs.upenn.edu
Principal Investigator: Douglas Beach, MD
United States, Washington
Harborview Madison Clinic	Recruiting
Seattle, Washington, United States, 98104
Contact: Kingsley Ndoh 206-667-3160 kndoh@fredhutch.org
Principal Investigator: Corey Casper, MD, MPH
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109
Contact: Peace Imani, MMED, MPH 206-667-3160 pimani@fhcrc.org
Contact: Lindsay Legg, LPN 206-744-8748 lmlegg@u.washington.edu
Principal Investigator: Corey Casper, MD
Virginia Mason Medical Center	Recruiting
Seattle, Washington, United States, 98111
Contact: Leila Ponce 206-342-6926 leila.ponce@vmmc.org
Principal Investigator: David Aboulafia, MD

Sponsors and Collaborators

AIDS Malignancy Consortium

National Cancer Institute (NCI)

The EMMES Corporation

AIDS and Cancer Specimen Resource

University of Arkansas

Investigators

Principal Investigator:	Lee Ratner, MD, PhD	Washington University Siteman Cancer Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:	NCT01567722 History of Changes
Other Study ID Numbers:	AMC-083; CDR0000729843 ( Other Identifier: NCI ); U01CA121947 ( U.S. NIH Grant/Contract )
First Posted:	March 30, 2012
Last Update Posted:	November 17, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Results will be submitted to dBGaP

Keywords provided by AIDS Malignancy Consortium:

HIV infection; adult diffuse large cell lymphoma; anal cancer	cervical cancer; non-small cell lung cancer; AIDS-related diffuse large cell lymphoma

Additional relevant MeSH terms:

Lymphoma; Uterine Cervical Neoplasms; Anus Neoplasms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site	Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases