Duke Spine Outcome Study (DSOS)

  • STATUS
    Recruiting
  • participants needed
    900
  • sponsor
    Duke University
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Updated on 16 February 2024
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cancer
spine surgery
metastasis
spinal diseases
metastatic disease
cancer diagnosis
spinal disease
neurosurgery

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.

Details
Condition Benign neoplasm of spinal cord, Spondylopathy
Age 18years - 85years
Clinical Study IdentifierNCT04217525
SponsorDuke University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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