Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00992303|
Recruitment Status : Recruiting
First Posted : October 9, 2009
Last Update Posted : April 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Unspecified Adult Solid Tumor, Protocol Specific||Other: biologic sample preservation procedure Other: medical chart review Other: questionnaire administration|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
- 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
- Disease outcome [ Time Frame: 5 years ]local recurrence, distant metastasis, overall survival by treatment regimen and disease site
- Toxicity by treatment regimen and disease site [ Time Frame: 1 year ]by treatment regimen and disease site
- Establishment of a prospective registry/database [ Time Frame: 10 years ]consisting of patient demographics and outcomes to be used for future research
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992303
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jean Wu, MSN 214-645-8525|
|Principal Investigator:||Hak Choy, MD||University of Texas Southwestern Medical Center - Dallas|