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

a study on Anal Cancer Colorectal Cancer Cervical Cancer Lung Cancer Lymphoma HIV/AIDS

Summary

for people ages 18 years and up (full criteria)
at UCLA UCSD
study started
estimated completion
William Wachsman, MD (ucsd) Ronald Mitsuyasu, MD (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Anal Cancer Cervical Cancer Lung Cancer Lymphoma HIV infection adult diffuse large cell lymphoma non-small cell lung cancer AIDS-related diffuse large cell lymphoma Uterine Cervical Neoplasms Anus Neoplasms DNA analysis RNA analysis gene expression analysis polymorphism analysis flow cytometry laboratory biomarker analysis medical chart review

Eligibility

For people ages 18 years and up

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 accepting new patients
    La Jolla California 92093-0658 United States
  • UCLA Clinical AIDS Research and Education (CARE) Center accepting new patients
    Los Angeles California 90095-1793 United States

Lead Scientists

  • William Wachsman, MD (ucsd)
    Senate Emeritus, Medicine. Authored (or co-authored) 52 research publications
  • Ronald Mitsuyasu, MD (ucla)
    Professor, Medicine. Authored (or co-authored) 75 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Malignancy Consortium
ID
NCT01567722
Study Type
Observational
Last Updated