Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
| Tracking Information | |||||
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| First Received Date ICMJE | March 29, 2012 | ||||
| Last Updated Date | May 3, 2013 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
Mutational spectrum of each type of HIV-1 associated malignancy [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01567722 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies | ||||
| Official Title ICMJE | Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Fresh-frozen tissue, Peripheral blood mononuclear cells |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | June 2015 | ||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01567722 | ||||
| Other Study ID Numbers ICMJE | CDR0000729843, AMC-083, U01CA121947 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | AIDS Malignancy Clinical Trials Consortium | ||||
| Study Sponsor ICMJE | AIDS Malignancy Clinical Trials Consortium | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | AIDS Malignancy Clinical Trials Consortium | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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