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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01567722
Recruitment Status : Recruiting
First Posted : March 30, 2012
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The Emmes Company, LLC
AIDS and Cancer Specimen Resource
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium

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.


Condition or disease Intervention/treatment
Lung Cancer Lymphoma Genetic: DNA analysis Genetic: RNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies
Actual Study Start Date : July 2012
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Lymphoma

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



Primary Outcome Measures :
  1. Mutational spectrum of each type of HIV-1 associated malignancy [ Time Frame: Study entry (prior to chemotherapy initiation) ]
    Complete genomic sequencing of HIV-1 associated tumor tissue


Biospecimen Retention:   Samples With DNA
Fresh-frozen tissue, peripheral blood mononuclear cells, formalin-fixed, paraffin-embedded tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567722


Locations
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United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Moores UCSD Cancer Center    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: William Wachsman, MD         
UCLA Clinical AIDS Research and Education (CARE) Center Recruiting
Los Angeles, California, United States, 90095-1793
Contact: Irma Franco-Gonzalez    310-825-6413    ifranco@mednet.ucla.edu   
Principal Investigator: Ronald Mitsuyasu, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Juan Carlos Ramos, MD    305-243-6611      
Principal Investigator: Juan Carlos Ramos, MD         
United States, Hawaii
Cancer Research Center of Hawaii Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Illinois
John H. Stroger Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Paul Rubinstein    312-864-7277      
Principal Investigator: Paul Rubinstein, MD         
United States, Louisiana
Louisiana State University Public Hospital Terminated
New Orleans, Louisiana, United States, 70112
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lee Ratner, MD, PhD    314-362-8836    lratner@im.wustl.edu   
Principal Investigator: Lee Ratner, MD         
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Joseph Sparano, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Ariela Noy, MD    212-639-7423    noya@mskcc.org   
Principal Investigator: Ariela Noy, MD         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Megan Sterlina, PA    919-962-0922    megan_fuchs@med.unc.edu   
Principal Investigator: Christopher Dittus, MD         
United States, Pennsylvania
University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Douglas Beach, MD    215-829-6088    douglas.beach@uphs.upenn.edu   
Principal Investigator: Douglas Beach, MD         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Deric Savior, MD    215-707-2777    Deric.Savior@tuhs.temple.edu   
Principal Investigator: Deric Savior, MD         
United States, Washington
Harborview Madison Clinic Terminated
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance Withdrawn
Seattle, Washington, United States, 98109
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98111
Contact: Rachel Dowty    206-287-6275    Rachel.Dowty@virginiamason.org   
Principal Investigator: David Aboulafia, MD         
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The Emmes Company, LLC
AIDS and Cancer Specimen Resource
University of Arkansas
Investigators
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Principal Investigator: Lee Ratner, MD, PhD Washington University Siteman Cancer Center
Additional Information:
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Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT01567722    
Other Study ID Numbers: AMC-083
CDR0000729843 ( Other Identifier: NCI )
U01CA121947 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be submitted to dBGaP

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AIDS Malignancy Consortium:
HIV infection
adult diffuse large cell lymphoma
non-small cell lung cancer
AIDS-related diffuse large cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases