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Registry Study to Evaluate the Clinical Outcome of Cancer Patients and Benign Diseases Treated With Radiation

Registry Study to Evaluate the Clinical Outcome of Cancer Patients and Benign Diseases Treated With Radiation at the University of Texas Southwestern Medical Center

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03617237
Enrollment
10000
Registered
2018-08-06
Start date
2012-07-03
Completion date
2032-04-18
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

Registry database repository for determining clinical outcomes primarily of patients who have received or have been evaluated for radiation treatment in either the definitive or palliative setting for both malignant and benign etiologies. To compare the outcomes with National Cancer Data Base (NCDB) of the American College of Surgeon(ACS).

Detailed description

Investigator will retrospectively collect and evaluate information from patients with cancer or benign etiologies to improve future clinical outcomes and help identify prospective outcomes study questions. This information will include patients' name, medical record number, medical history, diagnosis, treatment, laboratory test results, diagnostic test results, pathology reports, therapeutic and nontherapeutic results, surgical results, radiology results, radiation therapy details (dose, techniques, toxicity), concurrent use of chemotherapy/systemic therapy, quality of life outcomes,cachexia status, and primarily last follow-up data. All information will be collected after their standard of care visits.

Interventions

OTHERRetrospective Populations

All patients who are currently treated by any physician at the University of Texas Southwestern campus Aston Clinic, Seay Clinic, PHHS Clinic, Moncrief Radiation Oncology, St. Paul West Campus Radiation Oncology, East Radiation Oncology Clinic will be included in the registry. The data from the charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, date of birth, and social security number. 1. The research involves no more than minimal risk to the subjects. 2. The waiver will not adversely affect the rights and welfare of the subjects. 3. The research could not practicably be carried out without the waiver. 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

Any patient who received or was potentially evaluated for radiotherapy since 2000 for benign or malignant etiologies in the definitive or palliative setting. Patients with comparatively similar diagnosis and disease status at UTSW, but electing not to undergo radiation therapy, treated with surgical or systemic therapy, or best supportive care, being followed by an oncology specialist at UT Southwestern Medical Center will also be eligible for evaluation. -

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life Analysis10 yearsThe quality of life questionnaire will be used as a standardized instrument to measure the health outcome.Its provides a simple descriptive profile and a single index value for health status. The US version of the EQ-5D will be used, to enable mapping of general HR-QOL scores from EQ-5D scores into health state utility scores (ranging from 0 to 100) for the US population.Analyses will be performed for all subjects having received treatment for benign and cancer tumors. Information gained from this could lead to improved medical care for them. By performing comparative study for subgroups of patients with similar diseases but not treated with radiation therapy, potential benefits and risks of radiation therapy may be better delineated.

Countries

United States

Contacts

CONTACTSarah Neufeld, MS
sarah.hardee@utsouthwestern.edu2146458525
CONTACTDavid J Sher, MD, MPH
David.Sher@UTSouthwestern.edu214-645-8525
PRINCIPAL_INVESTIGATORDavid J Sher, MD, MPH

University of Texas Southwestern Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026