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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01567722
• Other study ID #: AMC-083
• Secondary ID: CDR0000729843U01
• Status: Terminated
• Start date: January 2, 2013
• Est. completion date: January 14, 2022

Study information

• Verified date: March 2023
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 114
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lymphoma

Intervention

Genetic:
• DNA analysis
This sample will be used for germline DNA analysis.
• RNA analysis
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
• 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.
• 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.
• 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.
• medical chart review
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.

Locations

Country	Name	City	State
United States	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	John H. Stroger Hospital of Cook County	Chicago	Illinois
United States	Moores UCSD Cancer Center	La Jolla	California
United States	UCLA Clinical AIDS Research and Education (CARE) Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Louisiana State University Public Hospital	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Harborview Madison Clinic	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	George Washington University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	AIDS and Cancer Specimen Resource, National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Tissue Specimen From Study Participants	Summary of the specimens available by study arm	Study entry (prior to chemotherapy initiation)

External Links

•   Clinicaltrials.gov summary of trial