Clinical trial · Observational
Duke Spine Outcome Study (DSOS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Temporary suspension due to staffing
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Disorder | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Spinal Disorders
- description
- This group includes patients with any spinal deformity or disorder coming in for treatment.
- label
- Spinal Tumors
- description
- This group includes patients with spinal tumors or metastasis of the spine, coming in for treatment.
Primary outcomes (6)
- measure
- Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)
- timeFrame
- Baseline, 6, 12, 26, 52, 104 weeks
- description
- 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.
- measure
- Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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 bone marrow diseases, including but not limited to diagnosed lymphomas, leukemias, sickle cell or other anemias not associated with their current condition. * Polycythemia vera. * Known or suspected immunodeficiency or Human Immunodeficiency Virus (HIV). * Hematocrit \< 24% pre-operatively.
References
Publications (0)
Data not yet available