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

This study is currently recruiting participants.
Verified May 2013 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01567722
First received: March 29, 2012
Last updated: May 3, 2013
Last verified: May 2013
  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:


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)
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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567722

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            
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
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: 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 23, 2013