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Clinical Trials/NCT00992303
NCT00992303
Recruiting
Not Applicable

Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants

University of Texas Southwestern Medical Center1 site in 1 country10,000 target enrollmentSeptember 2009

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2029
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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