Spinal TumorDSOSNCT04217525
Duke Spine Outcome Study (DSOS)
An observational study of Spinal Tumor and Spinal Disorder, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Tumor, Spinal Disorder
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 1 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with spinal disorders or spinal tumors.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
- Spinal Tumor, Spinal Disorder
- Medical subject headings
- Spinal Cord Neoplasms, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Disorders | This group includes patients with any spinal deformity or disorder coming in for treatment. | |
| Spinal Tumors | This group includes patients with spinal tumors or metastasis of the spine, coming in for treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)
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.
Measured: Baseline, 6, 12, 26, 52, 104 weeks
Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)
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.
Measured: Baseline, 6, 12, 26, 52, 104 weeks
Change in Quality of Life as measured by SF-36 version 2
Short-form health survey with 36 questions
Measured: Baseline, 6, 12, 26, 52, 104 weeks
Change in Health Status as measured by EQ-5D
It contains 5 questions and provides a simple descriptive profile and a single index value for health status.
Measured: Baseline, 6, 12, 26, 52, 104 weeks
Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 = Fully active to 5 = Dead
Measured: Baseline, 6, 12, 26, 52, 104 weeks
Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)
ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit.
Measured: Baseline, 6, 12, 26, 52, 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start3 Dec 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Temporary suspension due to staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney R. Goodwin, M.D., PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217525
- Sponsor's protocol ID
- Pro00101198
- Acronym
- DSOS
- Status last verified
- May 2026
- First submitted
- 31 Dec 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duke Spine Outcome Study (DSOS)
- ClinicalTrials.gov ID
- NCT04217525
- Acronym / sponsor ID
- DSOS / Pro00101198
- Conditions
- Spinal Tumor, Spinal Disorder
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Temporary suspension due to staffing
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Disorders | – | –This group includes patients with any spinal deformity or disorder coming in for treatment. |
| Spinal Tumors | – | –This group includes patients with spinal tumors or metastasis of the spine, coming in for treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal disorders or spinal tumors.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney R. Goodwin, M.D., PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Tumor and Spinal Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ) (time frame: Baseline, 6, 12, 26, 52, 104 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.