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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma; Lung Cancer
• Intervention / Treatment: Genetic: DNA analysis; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: polymorphism analysis; Other: biologic sample preservation procedure; Other: flow cytometry; Other: medical chart review

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0658
      • Moores UCSD Cancer Center
    • Los Angeles, California, United States, 90095-1793
      • UCLA Clinical AIDS Research and Education (CARE) Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Public Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein Cancer Center at Albert Einstein College of Medicine
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19106
      • University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital
  • Washington
    • Seattle, Washington, United States, 98111
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98104
      • Harborview Madison Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected males and females age 18 and older with one of the three malignancy types studied with available diagnostic biopsy material

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV-positive diffuse large B-cell lymphoma cases; Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.	Genetic: DNA analysis; This sample will be used for germline DNA analysis.; Genetic: RNA analysis; RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.; Genetic: gene expression analysis; Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.; Genetic: polymorphism analysis; Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.; Other: biologic sample preservation procedure; Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.; Other: flow cytometry; Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.; Other: medical chart review; Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
HIV-positive lung cancer cases; Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.	Genetic: DNA analysis; This sample will be used for germline DNA analysis.; Genetic: RNA analysis; RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.; Genetic: gene expression analysis; Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.; Genetic: polymorphism analysis; Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.; Other: biologic sample preservation procedure; Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.; Other: flow cytometry; Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.; Other: medical chart review; Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
HIV-positive cervical cancer cases; Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of Tissue Specimen From Study Participants	Summary of the specimens available by study arm	Study entry (prior to chemotherapy initiation)

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); University of Arkansas; The Emmes Company, LLC; AIDS and Cancer Specimen Resource

Publications and helpful links

Helpful Links

• Clinicaltrials.gov summary of trial

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2013
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; AIDS-related diffuse large cell lymphoma; HIV infection; adult diffuse large cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: AMC-083; U01CA121947 (U.S. NIH Grant/Contract); CDR0000729843 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be submitted to dBGaP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No