Duke Spine Outcome Study (DSOS)

Duke University

Status

Suspended

Conditions

Spinal Tumor

Spinal Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT04217525

Pro00101198

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.