Clinical trial NCT04217525: Duke Spine Outcome Study (DSOS)
Official title: Duke Spine Outcome Study (DSOS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Tumor
Spinal Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal disorders or spinal tumors.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)
timeFrame: Baseline, 6, 12, 26, 52, 104 weeks
measure: Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)
timeFrame: Baseline, 6, 12, 26, 52, 104 weeks
measure: Change in Quality of Life as measured by SF-36 version 2
timeFrame: Baseline, 6, 12, 26, 52, 104 weeks
measure: Change in Health Status as measured by EQ-5D
timeFrame: Baseline, 6, 12, 26, 52, 104 weeks
measure: Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline, 6, 12, 26, 52, 104 weeks
measure: Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)
timeFrame: Baseline, 6, 12, 26, 52, 104 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Courtney R. Goodwin, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: