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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617237
• Other study ID #: STU 052012-019
• Status: Recruiting
• Start date: July 3, 2012
• Est. completion date: April 18, 2032

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Sarah Neufeld, MS
• Phone: 2146458525
• Email: sarah.hardee[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: April 18, 2032
• Est. primary completion date: July 10, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Retrospective 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. The research involves no more than minimal risk to the subjects. The waiver will not adversely affect the rights and welfare of the subjects. The research could not practicably be carried out without the waiver. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Centre	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Analysis	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.	10 years