Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Maintenance a Tissue Resource and Registry/Database
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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. Healthy participants will also be allowed on the trial so their samples can be used in comparison to patients with malignancy
Detailed Description
OBJECTIVES: Primary * To maintain and create a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database that will be used to explore genetic variations contributing to clinical outcomes through tissue analysis and outcome correlation. Tissue will be stored by the UTSTR and the database managed by Radiation Oncology. Secondary * To document disease outcome (local recurrence, distant metastasis, overall survival) by treatment regimen and disease site. * To document toxicity by treatment regimen and disease site. * To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research. 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.
Investigators
Robert Timmerman
Professor
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maintenance a Tissue Resource and Registry/Database
Time Frame: 10 years
Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database
Secondary Outcomes
- Local recurrence(5 years)
- Distant metastasis(5 years)
- Toxicity by treatment regimen(1 year)
- Overall survival(5 years)
- Establishment of a prospective registry/database(10 years)