Clinical trial NCT03617237: Registry Study to Evaluate the Clinical Outcome of Cancer Patients and Benign Diseases Treated with Radiation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Quality of Life Analysis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Centre
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: David J Sher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: