Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
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ClinicalTrials.gov Identifier: NCT01567722 |
Recruitment Status
:
Recruiting
First Posted
: March 30, 2012
Last Update Posted
: November 17, 2017
|
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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 |
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 |
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 |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | June 2020 |

- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
- 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
PATIENT CHARACTERISTICS:
- Participants must be willing and able to sign an IRB-approved informed consent document
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics

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
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: Maricela Gonzalez 310-557-3729 mmgonzalez@mednet.ecla.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 | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Eileen Mederos 504-568-3235 emede1@lsuhsc.edu | |
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 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: Missak Haigentz, 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 Hills, North Carolina, United States, 27599 | |
Contact: Kristy Richards, MD kristy_richards@med.unc.edu | |
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 douglas.beach@uphs.upenn.edu | |
Principal Investigator: Douglas Beach, MD | |
United States, Washington | |
Harborview Madison Clinic | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Kingsley Ndoh 206-667-3160 kndoh@fredhutch.org | |
Principal Investigator: Corey Casper, MD, MPH | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Peace Imani, MMED, MPH 206-667-3160 pimani@fhcrc.org | |
Contact: Lindsay Legg, LPN 206-744-8748 lmlegg@u.washington.edu | |
Principal Investigator: Corey Casper, MD | |
Virginia Mason Medical Center | Recruiting |
Seattle, Washington, United States, 98111 | |
Contact: Leila Ponce 206-342-6926 leila.ponce@vmmc.org | |
Principal Investigator: David Aboulafia, MD |
Principal Investigator: | Lee Ratner, MD, PhD | Washington University Siteman Cancer Center |
Responsible Party: | AIDS Malignancy Consortium |
ClinicalTrials.gov Identifier: | NCT01567722 History of Changes |
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: | November 17, 2017 |
Last Verified: | November 2017 |
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:
Lymphoma Uterine Cervical Neoplasms Anus Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
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 |