NCT00992303

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	biologic sample preservation procedure
OTHER	medical chart review
OTHER	questionnaire administration

Timeline

• Start date: 2009-09-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2009-10-09
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States