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

18 Years
Open (Enrolling)
Anal Cancer, Cervical Cancer, Lung Cancer, Lymphoma, Nonneoplastic Condition

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Trial Information

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

Inclusion Criteria


- Participants must have a diagnosis of a malignancy or clinical findings suggestive of
a possible HIV-associated malignancy of one of four types:

- Diffuse large B-cell lymphoma

- Non-small cell lung malignancy

- Anal cancer

- Cervical cancer

- The presence of any of the following conditions will exclude a participant from study

- 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


- See Disease Characteristics

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Mutational spectrum of each type of HIV-1 associated malignancy

Outcome Description:

Complete genomic sequencing of HIV-1 associated tumor tissue

Outcome Time Frame:

Study entry (prior to chemotherapy initiation)

Safety Issue:


Principal Investigator

Lee Ratner, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2012

Completion Date:

June 2015

Related Keywords:

  • Anal Cancer
  • Cervical Cancer
  • Lung Cancer
  • Lymphoma
  • Nonneoplastic Condition
  • HIV infection
  • adult diffuse large cell lymphoma
  • anal cancer
  • cervical cancer
  • non-small cell lung cancer
  • AIDS-related diffuse large cell lymphoma
  • Anus Neoplasms
  • Uterine Cervical Neoplasms
  • Lung Neoplasms
  • Lymphoma



Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
UCLA Clinical AIDS Research and Education (CARE) CenterLos Angeles, California  90024
University of MiamiMiami, Florida  33136
AIDS Associated Malignancies Clinical Trials ConsortiumSaint Louis, Missouri  63110