Duke Spine Outcome Study (DSOS) (NCT04217525) | Clinical Trial Compass
SuspendedNot Applicable
Duke Spine Outcome Study (DSOS)
Stopped: Temporary suspension due to staffing
United States900 participantsStarted 2019-12-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 85 years.
* Able to read and write local language at an elementary level.
* Diagnosis of primary or metastatic tumor of the spine ); or
* Infection of the spine; or
* Instability of the spine; or
* Injury of the spine.
* Accessibility for treatment and follow up.
* Patient consent obtained according to Duke institutional policy.
Inclusion criteria for spine surgery (control population for bone marrow specimens)
* Age between 18 and 85 years.
* Spine surgery to be performed at Duke University Medical Center (DUMC) under the auspices of the neurosurgery program.
* No concurrent cancer diagnosis.
* Accessibility for treatment and follow up.
* Patient consent obtained according to Duke institutional policy.
Exclusion Criteria:
* History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening
* Is a prisoner.
* A disease or condition that would, in opinion of the investigator, preclude accurate evaluation
(e.g. significant psychiatric disease), or that would impair the ability of the patient to receive protocol treatment or comply with protocol.
* Pregnant or breast feeding during the study period (women of child-bearing potential will require a negative serum pregnancy test within 30 days of enrollment).
* Active infection, or fever of unknown origin.
* Inflammatory bowel disease.
* Systemic lupus erythematosus.
* Rheumatoid arthritis, or other autoimmune disease.
* History of or active hematologic or b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)
Timeframe: Baseline, 6, 12, 26, 52, 104 weeks
2
Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)
Timeframe: Baseline, 6, 12, 26, 52, 104 weeks
3
Change in Quality of Life as measured by SF-36 version 2
Timeframe: Baseline, 6, 12, 26, 52, 104 weeks
4
Change in Health Status as measured by EQ-5D
Timeframe: Baseline, 6, 12, 26, 52, 104 weeks
5
Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status
Timeframe: Baseline, 6, 12, 26, 52, 104 weeks
6
Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)