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



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Lymphoma, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:July 2012
End Date:June 2020

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Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies

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.

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.

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
We found this trial at
14
sites
1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Principal Investigator: Missak Haigentz, MD
Phone: 718-904-2730
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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Bronx, NY
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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Honolulu, HI
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Juan Carlos Ramos, MD
Phone: 305-243-6611
University of Miami A private research university with more than 15,000 students from around the...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Corey Casper, MD
Phone: 206-667-3160
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Chapel Hill, North Carolina 27599
Principal Investigator: Kristy Richards, MD
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Chicago, Illinois 60612
Principal Investigator: Paul Rubinstein, MD
Phone: 312-864-7277
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La Jolla, California 92093
Principal Investigator: William Wachsman, MD
Phone: 858-822-5354
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Los Angeles, California 90095
Principal Investigator: Ronald Mitsuyasu, MD
Phone: 310-557-3729
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New Orleans, Louisiana 70112
Principal Investigator: Thomas Reske, MD
Phone: 504-568-3235
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New Orleans, LA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Ariela Noy, MD
Phone: 212-639-7423
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19106
Principal Investigator: Douglas Beach, MD
Phone: 215-829-6088
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Lee Ratner, MD
Phone: 314-362-8836
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Seattle, Washington 98104
Principal Investigator: Corey Casper, MD, MPH
Phone: 206-667-3160
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: David Aboulafia, MD
Phone: 206-342-6926
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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