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NCT Number: NCT03617237

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

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).

Recruiting

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Centre

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Sarah Neufeld, MS

CONTACT

[email protected]

214-648-1836

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

  • 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.

Primary outcomes

  1. Quality of Life Analysis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David J Sher, MD, MPH

CONTACT

[email protected]

214-645-8525

Sarah Neufeld, MS

CONTACT

[email protected]

2146458525

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2030
Study completion
2032
First posted
Aug 6, 2018
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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