Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy
| Tracking Information | |||||
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| First Received Date ICMJE | October 8, 2009 | ||||
| Last Updated Date | July 25, 2012 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Maintenance a Tissue Resource and Registry/Database [ Time Frame: 10 years ] [ Designated as safety issue: No ] Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database |
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| Original Primary Outcome Measures ICMJE |
Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00992303 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy | ||||
| Official Title ICMJE | Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients | ||||
| Brief Summary | RATIONALE: Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting tissue samples from patients with cancer undergoing radiation therapy. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Tissue, including surgical waste, venous blood/serum, urine, bone marrow, and other body fluids, may be collected (at planned surgery and routine medical visits) and preserved for future research. Demographic and disease and treatment information is obtained from patients (by interview or questionnaire), from medical records, and from national datasets. Patients may also be asked to provide additional blood samples and/or a small skin-punch biopsy sample. Patients are followed up every 6 months for the first two years following treatment and then yearly thereafter. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Cancer patients |
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| Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | ||||
| 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 | 10000 | ||||
| Estimated Completion Date | December 2020 | ||||
| Estimated Primary Completion Date | December 2020 (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 | NCT00992303 | ||||
| Other Study ID Numbers ICMJE | CDR0000653406, SCCC-032009-049, IRB# 8843 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Texas Southwestern Medical Center | ||||
| Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Texas Southwestern Medical Center | ||||
| Verification Date | October 2009 | ||||
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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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