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

Recruiting

• Conditions: Cancer

• Registration Number: NCT03617237
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2012-07-03
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2030-07-10
• Study Completion: 2032-04-18

Recruitment & Eligibility

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

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. -

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life Analysis	10 years	The 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.

Trial Locations

Locations (1)

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