COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. Identifier: NCT01567722
Recruitment Status : Recruiting
First Posted : March 30, 2012
Last Update Posted : March 24, 2020
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
Anal Cancer Cervical Cancer 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:


  • 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
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 : June 2020
Estimated Study Completion Date : June 2020

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

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.

Layout table for eligibility information
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


  • 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
    • Cervical cancer
  • 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


  • Participants must be willing and able to sign an IRB-approved informed consent document


  • 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 identifier (NCT number): NCT01567722

Layout table for location information
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   
Principal Investigator: William Wachsman, MD         
UCLA Clinical AIDS Research and Education (CARE) Center Recruiting
Los Angeles, California, United States, 90095-1793
Contact: Maricela Gonzalez    310-557-3729   
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 Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Eileen Mederos    504-568-3235   
Principal Investigator: Thomas Reske, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lee Ratner, MD, PhD    314-362-8836   
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   
Principal Investigator: Missak Haigentz, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Ariela Noy, MD    212-639-7423   
Principal Investigator: Ariela Noy, MD         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kristy Richards, MD   
Principal Investigator: Kristy Richards, 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   
Principal Investigator: Douglas Beach, MD         
United States, Washington
Harborview Madison Clinic Recruiting
Seattle, Washington, United States, 98104
Contact: Kingsley Ndoh    206-667-3160   
Principal Investigator: Corey Casper, MD, MPH         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Peace Imani, MMED, MPH    206-667-3160   
Contact: Lindsay Legg, LPN    206-744-8748   
Principal Investigator: Corey Casper, MD         
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98111
Contact: Leila Ponce    206-342-6926   
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
Layout table for investigator information
Principal Investigator: Lee Ratner, MD, PhD Washington University Siteman Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: AIDS Malignancy Consortium 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: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be submitted to dBGaP
Keywords provided by AIDS Malignancy Consortium:
HIV infection
adult diffuse large cell lymphoma
anal cancer
cervical cancer
non-small cell lung cancer
AIDS-related diffuse large cell lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Anus Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases