Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients
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.
Observational
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Maintenance a Tissue Resource and Registry/Database
Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database
10 years
No
Hak Choy, MD
Principal Investigator
University of Texas Southwestern Medical Center - Dallas
United States: Food and Drug Administration
CDR0000653406
NCT00992303
September 2009
December 2020
Name | Location |
---|---|
Ut Southwestern Medical Center | Dallas, Texas 75390 |