Collecting and Storing Tissue Samples from Patients with HIV-Associated Malignancies

Status: Active

Description

This research trial studies tissue samples from patients with human immunodeficiency virus (HIV)-related malignancies. Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Eligibility Criteria

Inclusion Criteria

  • Participants must have a diagnosis of HIV-associated malignancy of one of three types: * Diffuse large B-cell lymphoma * Non-small cell lung malignancy * Cervical cancer
  • Tumors will be accepted that have had previous neoadjuvant/chemotherapy treatment, but the specific treatment regimen must be noted and communicated to the Office of Cancer Genomics (OCG)
  • Tumors from participants with previous malignancies will be accepted, but any previous malignancies must be noted and communicated to the OCG
  • 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
  • Participants must be willing and able to sign an Institutional Review Board (IRB)-approved informed consent document that permits the use of samples for genomic-based molecular characterization projects
  • The site must ensure the minimum specimen requirements for HTMCP case submission can be met, including the availability of/ability to collect: * Tumor tissue for genomic analysis that was collected prior to initiating treatment for the malignancy (preferable); repeat tumor biopsy will not be performed solely to meet the protocol specimen collection requirements; acceptable tissue includes: ** Flash-frozen diagnostic tumor biopsy tissue (minimum specimen size of 10 x 10 x 2 mm, approximately 100 mg) ** Formalin-fixed, paraffin-embedded (FFPE) tumor biopsy material tissue which may include a tissue block OR tissue scrolls and slides for molecular quality control (QC) if a block is not released ** Tumor tissue sample with specifications other than those noted above for which the Office of Cancer Genomics (OCG) has provided written approval for submission to project * A 10 ml blood specimen for peripheral blood mononuclear cell (PBMC) isolation; blood samples should be collected prior to treatment initiation for the malignancy if possible, but may be collected after treatment initiation if necessary * Diagnostic FFPE tissue block for central pathology review; if the diagnostic tissue block is not available, another representative FFPE tissue block that was collected from an area near the location of the diagnostic biopsy may be submitted for pathology review; the site may submit fifteen formalin-fixed, unstained slides for participants with diffuse large B-cell lymphoma (DLBCL), or five slides for all other malignancy types only if the institution will not release a tissue block (3 slides for cervical tissue, 4 slides for lung tissue or 12 slides for DLBCL tissue) * Completed HTMCP enrollment form for the applicable tumor type

Exclusion Criteria

  • Inability to provide informed consent

Locations & Contacts

California

La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Lee Ratner
Phone: 314-362-8836
Email: lratner@dom.wustl.edu
Los Angeles
UCLA Center for Clinical AIDS Research and Education
Status: Active
Contact: Ronald T. Mitsuyasu
Phone: 310-557-9680
Email: rmitsuya@mednet.ucla.edu
San Diego
University of California San Diego
Status: Active
Contact: William Wachsman
Phone: 858-522-8585
Email: wwachsman@uscd.edu

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Contact: Lee Ratner
Phone: 314-362-8836
Email: lratner@dom.wustl.edu

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu

Louisiana

New Orleans
Louisiana State University Health Science Center
Status: Active
Contact: Lee Ratner
Phone: 314-362-8836
Email: lratner@dom.wustl.edu
University Medical Center New Orleans
Status: Active
Contact: Lee Ratner
Phone: 314-362-8836
Email: lratner@wustl.edu

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Richard F. Ambinder
Phone: 410-955-8839
Email: ambinri@jhmi.edu

Missouri

Saint Loius
Washington University - Jewish
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Contact: Lee Ratner
Phone: 314-362-8836
Email: lratner@dom.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Lee Ratner
Phone: 314-362-8836
Email: lratner@dom.wustl.edu

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Ariela Noy
Phone: 212-639-7423
Email: noya@mskcc.org

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Dirk Peter Dittmer
Phone: 919-966-7960
Email: ddittmer@med.unc.edu

Pennsylvania

Philadelphia
Pennsylvania Oncology Hematology Associates
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu
Temple University Hospital
Status: Active
Contact: Lee Ratner
Email: info@siteman.wustl.edu
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Douglas Francis Beach
Phone: 215-829-6088
Email: douglas.beach@uphs.upenn.edu

Washington

Seattle
Virginia Mason Medical Center
Status: Active
Contact: David M. Aboulafia
Phone: 206-223-6193
Email: hemdma@vmmc.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To obtain high-quality, clinically annotated tissue from patients with HIV-1 malignancy.

OUTLINE:

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 1 year, and 2 years for data-reporting purposes.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Ancillary-correlative

Lead Organization

Lead Organization
AIDS Malignancy Consortium

Principal Investigator
Lee Ratner

Trial IDs

Primary ID AMC-083
Secondary IDs NCI-2012-00718, CDR0000729843
Clinicaltrials.gov ID NCT01567722