Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
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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 |
- 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 |
HIV-infected males and females age 18 and older with one of the four 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 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| United States, California | |
| UCLA Clinical AIDS Research and Education (CARE) Center | Recruiting |
| Los Angeles, California, United States, 90095-1793 | |
| Contact: Ronald Mitsuyasu, MD 310-557-9680 | |
| 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 | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Bruce Shiramizu, MD 808-737-2751 | |
| United States, Missouri | |
| AIDS Associated Malignancies Clinical Trials Consortium | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Lee Ratner, MD, PhD 314-362-8836 lratner@im.wustl.edu | |
| 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 | |
| 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: | CDR0000729843, AMC-083, U01CA121947 |
| Study First Received: | March 29, 2012 |
| Last Updated: | May 3, 2013 |
| 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:
|
Anus Neoplasms Uterine Cervical Neoplasms Lung Neoplasms Lymphoma Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases |
Rectal Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
ClinicalTrials.gov processed this record on May 22, 2013