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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01567722
Recruitment Status : Recruiting
First Posted : March 30, 2012
Last Update Posted : November 17, 2017
National Cancer Institute (NCI)
The EMMES Corporation
AIDS and Cancer Specimen Resource
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium

March 29, 2012
March 30, 2012
November 17, 2017
July 2012
June 2020   (Final data collection date for primary outcome measure)
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
Mutational spectrum of each type of HIV-1 associated malignancy
Complete list of historical versions of study NCT01567722 on Archive Site
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Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
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.


  • 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.

Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Fresh-frozen tissue, Peripheral blood mononuclear cells
Non-Probability Sample
HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material
  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2020
June 2020   (Final data collection date for primary outcome measure)


  • 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


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


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
United States
CDR0000729843 ( Other Identifier: NCI )
U01CA121947 ( U.S. NIH Grant/Contract )
Not Provided
Plan to Share IPD: Yes
Plan Description: Results will be submitted to dBGaP
AIDS Malignancy Consortium
AIDS Malignancy Consortium
  • National Cancer Institute (NCI)
  • The EMMES Corporation
  • AIDS and Cancer Specimen Resource
  • University of Arkansas
Principal Investigator: Lee Ratner, MD, PhD Washington University Siteman Cancer Center
AIDS Malignancy Consortium
November 2017