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

NCT ID: NCT03617237

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-03
• Study Completion Date: 2032-04-18

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.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Sher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J Sher, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Centre

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Neufeld, MS

Role: CONTACT

sarah.hardee@utsouthwestern.edu

2146458525

David J Sher, MD, MPH

Role: CONTACT

David.Sher@UTSouthwestern.edu

214-645-8525

Facility Contacts

Sarah Neufeld, MS

Role: primary

Sarah.Hardee@UTSouthwestern.edu

214-648-1836

Other Identifiers

STU 052012-019

Identifier Type: -

Identifier Source: org_study_id