AIDS and Cancer Specimen Bank (ACSB)
| Tracking Information | |||||
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| First Received Date ICMJE | December 24, 2007 | ||||
| Last Updated Date | April 20, 2011 | ||||
| Start Date ICMJE | June 1997 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Identify and improve access to tumor tissue, biological specimens, and associated clinical outcome data that could be utilized for research by the research community at-large on the pathogenesis of HIV and non-HIV associated malignancies. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00587912 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 | AIDS and Cancer Specimen Bank (ACSB) | ||||
| Official Title ICMJE | AIDS and Cancer Specimen Bank (ACSB) | ||||
| Brief Summary | The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies. The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease. |
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| Detailed Description | The overall goal of the AIDS and Cancer Specimen Bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non- AIDS associated malignancies. These specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. Contents of the ACSB will be made available to researchers through an application to the National Cancer Institute. Strict patient confidentiality protection guidelines are in place for all specimens in the ACSB. The objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the AIDS Malignancies Consortium, and from other patients with and without HIV infection, who have AIDS-Associated malignancies. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood, urine, other bodily fluids (eg, pleural fluid), and tumor tissue obtained from patients. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | The Source of specimens will include patients screened for participation on protocols conducted by the AIDS Malignancy Consortium, as well as other patients with HIV infection and cancer who are not eligible for participation in AMC trials, and patients without HIV who have malignancies associated with HIV or with immunosuppression. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 65 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00587912 | ||||
| Other Study ID Numbers ICMJE | 97-043 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | David Straus, MD, Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | April 2011 | ||||
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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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