Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
Conditions
Anal Cancer - Cervical Cancer - Lung Cancer - Lymphoma - Nonneoplastic Condition
Conditions: official terms
Anus Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
HIV infection, adult diffuse large cell lymphoma, anal cancer, cervical cancer, non-small cell lung cancer, AIDS-related diffuse large cell lymphoma
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: DNA analysis Type: Genetic
Name: RNA analysis Type: Genetic
Name: gene expression analysis Type: Genetic
Name: polymorphism analysis Type: Genetic
Name: biologic sample preservation procedure Type: Other
Name: flow cytometry Type: Other
Name: laboratory biomarker analysis Type: Other
Name: medical chart review Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Moores UCSD Cancer Center
La Jolla, California, United States
Status: Recruiting
Contact: Clinical Trials Office - Moores UCSD Cancer Center - 858-822-5354 - cancercto@ucsd.edu
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
Status: Recruiting
Contact: Maricela Gonzalez - 310-557-3729 - mmgonzalez@mednet.ecla.edu
University of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Juan Carlos Ramos, MD - 305-243-6611
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Status: Withdrawn
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States
Status: Recruiting
Contact: Erika Radeke - 312-864-5204
Louisiana State University Public Hospital
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Eileen Mederos - 504-568-3235 - emede1@lsuhsc.edu
Washington University School of Medicine
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Lee Ratner, MD, PhD - 314-362-8836 - lratner@im.wustl.edu
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States
Status: Recruiting
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe - 718-904-2730 - aecc@aecom.yu.edu
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Ariela Noy, MD - 212-639-7423 - noya@mskcc.org
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Kristy Richards, MD - kristy_richards@med.unc.edu
Harborview Madison Clinic
Seattle, Washington, United States
Status: Recruiting
Contact: Kingsley Ndoh - 206-667-3160 - kndoh@fredhutch.org
Seattle Cancer Care Alliance
Seattle, Washington, United States
Status: Suspended
Virginia Mason Medical Center
Seattle, Washington, United States
Status: Active, not recruiting
Start Date
July 2012
Completion Date
June 2020
Sponsors
AIDS Malignancy Clinical Trials Consortium
Source
AIDS Malignancy Clinical Trials Consortium
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page