Duke Spine Outcome Study (DSOS)

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 900

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life as measured by SF-36 version 2	Baseline, 6, 12, 26, 52, 104 weeks	Short-form health survey with 36 questions
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)	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)	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 Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)	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.
Change in Health Status as measured by EQ-5D	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	Baseline, 6, 12, 26, 52, 104 weeks	Grade 0 = Fully active to 5 = Dead

Secondary Outcome Measures

Name	Time	Method

Duke Spine Outcome Study (DSOS)

Recruitment & Eligibility

Study & Design

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