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

AIDS Malignancy Consortium

Status: Terminated

Conditions: Lung Cancer; Lymphoma

Treatments: Other: biologic sample preservation procedure; Genetic: DNA analysis; Other: medical chart review; Genetic: polymorphism analysis; Genetic: gene expression analysis; Other: flow cytometry; Genetic: RNA analysis

Study type: Observational

Funder types: Other; NETWORK; Industry; NIH

Identifiers

NCT01567722

U01CA121947 (U.S. NIH Grant/Contract)

AMC-083

CDR0000729843 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

• 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

Trial design

114 participants in 3 patient groups

HIV-positive diffuse large B-cell lymphoma cases

Description:

Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.

Treatment:

Genetic: polymorphism analysis

Genetic: RNA analysis

Other: biologic sample preservation procedure

Genetic: DNA analysis

Other: medical chart review

Genetic: gene expression analysis

Other: flow cytometry

HIV-positive lung cancer cases

Description:

Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.

Treatment:

Genetic: polymorphism analysis

Genetic: RNA analysis

Other: biologic sample preservation procedure

Genetic: DNA analysis

Other: medical chart review

Genetic: gene expression analysis

Other: flow cytometry

HIV-positive cervical cancer cases

Description:

Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer