Duke Spine Outcome Study (DSOS) (DSOS)
|ClinicalTrials.gov Identifier: NCT04217525|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
The primary goal of this registry is to increase the knowledge about spine tumors and other spine disorders to guide appropriate management strategies for the future. This registry will include the review of medical records, data collection for health related quality of life questionnaires, and collected tissues and samples.
The study will require obtaining spinal lesions (tumor, etc.), blood, and bone marrow samples (from non-lesional bone) from selected patients, which will be collected during your surgery.
|Condition or disease|
|Spinal Tumor Spinal Disorder|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||900 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Duke Spine Outcome Study (DSOS)|
|Actual Study Start Date :||December 3, 2019|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
This group includes patients with any spinal deformity or disorder coming in for treatment.
This group includes patients with spinal tumors or metastasis of the spine, coming in for treatment.
- Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ) [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]It is made up of 5 domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the 36-Item Short Form Survey (SF-36) for patients with spine tumors. The reliability and validity of this questionnaire will be compared with the SF-36v2.
- Change in Pain Score as measured by Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.
- Change in Quality of Life as measured by SF-36 version 2 [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]Short-form health survey with 36 questions
- Change in Health Status as measured by EQ-5D [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]It contains 5 questions and provides a simple descriptive profile and a single index value for health status.
- Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]Grade 0 = Fully active to 5 = Dead
- Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217525
|Contact: Alexia Bwensaemail@example.com|
|Contact: Beth Perry, RNfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Alexia Bwensa 919-681-5484 email@example.com|
|Principal Investigator: Courtney R. Goodwin, M.D., PhD|
|Principal Investigator:||Courtney R. Goodwin, M.D., PhD||Duke University|