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

NCT03617237 | Recruiting DMC

• 1 other identifier: STU 052012-019
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Retrospective Populations OTHER

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Risk will be minimized by protecting patient data through the use of deidentification of patient identifiers and password protected data collection. The information will be given only to faculty members and statisticians involved in the research project. The information will include the parameters attached in the spreadsheet supplied with the IRB submission. The data will be disclosed only for analytical purposes.Confidentiality will be maintained by adhering to HIPAA guidelines. Only the PI and other study team members will have access to that data.

You may qualify if:

• 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. -

You may not qualify if:

• None

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Centre

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• David J Sher, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Neufeld, MS

CONTACT

2146458525; sarah.hardee@utsouthwestern.edu

David J Sher, MD, MPH

CONTACT

214-645-8525; David.Sher@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: August 6, 2018
• Study Start: July 3, 2012
• Primary Completion (Estimated): July 10, 2030
• Study Completion (Estimated): April 18, 2032
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)