Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT00992303
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2009-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Tissue Procurement and Outcome Collection for Radiotherapy Treated Patients and Healthy Participants
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: