Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
AIDS Malignancy Clinical Trials Consortium
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01567722
First received: March 29, 2012
Last updated: October 29, 2014
Last verified: October 2014
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Purpose
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 | Intervention |
|---|---|
|
Anal Cancer Cervical Cancer Lung Cancer Lymphoma Nonneoplastic Condition |
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Anal Cancer
Lymphoma, Large-cell
Lymphosarcoma
U.S. FDA Resources
Further study details as provided by AIDS Malignancy Clinical Trials Consortium:
Primary Outcome Measures:
- Mutational spectrum of each type of HIV-1 associated malignancy [ Time Frame: Study entry (prior to chemotherapy initiation) ] [ Designated as safety issue: No ]Complete genomic sequencing of HIV-1 associated tumor tissue
Biospecimen Retention: Samples With DNA
Fresh-frozen tissue, Peripheral blood mononuclear cells
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-infected males and females age 18 and older with one of the four 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 four types:
- Diffuse large B-cell lymphoma
- Non-small cell lung malignancy
- Anal cancer
- 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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567722
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567722
Locations
| 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 | Suspended |
| Los Angeles, California, United States, 90095-1793 | |
| 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: Erika Radeke 312-864-5204 | |
| 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 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | 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 | Suspended |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| UNC Lineberger Comprehensive Cancer Center | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Kristy Richards, MD kristy_richards@med.unc.edu | |
| Principal Investigator: Kristy Richards, MD | |
| United States, Washington | |
| Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center | Suspended |
| Seattle, Washington, United States, 98111 | |
| Harborview Madison Clinic | Suspended |
| Seattle, Washington, United States, 98104 | |
| Seattle Cancer Care Alliance | Suspended |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
The EMMES Corporation
Investigators
| Principal Investigator: | Lee Ratner, MD, PhD | Washington University Siteman Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT01567722 History of Changes |
| Other Study ID Numbers: | AMC-083, CDR0000729843, U01CA121947 |
| Study First Received: | March 29, 2012 |
| Last Updated: | October 29, 2014 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by AIDS Malignancy Clinical Trials 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:
|
Uterine Cervical Neoplasms Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site |
Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms |
ClinicalTrials.gov processed this record on February 27, 2015