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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617237
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
David Sher, University of Texas Southwestern Medical Center

Study Description
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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).


Condition or disease Intervention/treatment
Cancer Other: Retrospective Populations

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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : July 3, 2012
Estimated Primary Completion Date : July 10, 2030
Estimated Study Completion Date : April 18, 2032
Groups and Cohorts
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Intervention Details:
  • 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.

    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.

Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617237


Contacts
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Contact: Sarah Neufeld, MS 2146458525 sarah.hardee@utsouthwestern.edu
Contact: Kajal Desai, MS 2146458525 kajal.desai@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Centre Recruiting
Dallas, Texas, United States, 75390
Contact: Sarah Neufeld, MS    214-648-1836    Sarah.Hardee@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: David J Sher, MD, MPH UT Southwestern Medical Center
More Information
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Responsible Party: David Sher, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03617237    
Other Study ID Numbers: STU 052012-019
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No