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

NCT01567722 | Terminated Results

• 3 other identifiers: AMC-083CDR0000729843U01CA121947
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Lung Cancer; Lymphoma

Keywords

HIV infection; adult diffuse large cell lymphoma; non-small cell lung cancer; AIDS-related diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Collection of Tissue Specimen From Study Participants

  Summary of the specimens available by study arm

  Study entry (prior to chemotherapy initiation)

Study Arms (3)

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

HIV-positive lung cancer cases

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

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

HIV-positive cervical cancer cases

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

Interventions

DNA analysis GENETIC

This sample will be used for germline DNA analysis.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

RNA analysis GENETIC

RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

gene expression analysis GENETIC

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.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

polymorphism analysis GENETIC

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.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

biologic sample preservation procedure OTHER

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.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

flow cytometry OTHER

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.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

medical chart review OTHER

Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.

HIV-positive diffuse large B-cell lymphoma cases; HIV-positive lung cancer cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (14)

Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, 90095-1793, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Louisiana State University Public Hospital

New Orleans, Louisiana, 70112, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Harborview Madison Clinic

Seattle, Washington, 98104, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Related Links

• Clinicaltrials.gov summary of trial

Biospecimen

Retention: SAMPLES WITH DNA

Fresh-frozen tissue, peripheral blood mononuclear cells, formalin-fixed, paraffin-embedded tissue

MeSH Terms

Conditions

Lung Neoplasms; Lymphoma; HIV Infections; Lymphoma, Large B-Cell, Diffuse; Carcinoma, Non-Small-Cell Lung

Interventions

Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis; Flow Cytometry

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Madhu Mazumdar
• Organization: AMC Statistical Center

madhu.mazumdar@mountsinai.org

(212) 659-9558

Study Officials

• Lee Ratner, MD, PhD

  Washington University Siteman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: March 30, 2012
• Study Start: January 2, 2013
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: March 16, 2023
• Results First Posted: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (14)