Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants

Recruiting

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00992303
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maintenance a Tissue Resource and Registry/Database	10 years	Maintenance and creation of a University of Texas Southwestern Medical Center (UTSW) Radiation Oncology Tissue Resource and Registry/Database

Secondary Outcome Measures

Name	Time	Method
Local recurrence	5 years	To document local recurrence by treatment regimen and disease site.
Distant metastasis	5 years	To document distant metastasis by treatment regimen and disease site.
Toxicity by treatment regimen	1 year	To document toxicity by treatment regimen and disease site.
Overall survival	5 years	To document overall survival by treatment regimen and disease site.
Establishment of a prospective registry/database	10 years	To establish a prospective registry/database consisting of patient demographics and outcomes to be used for future research.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States