Registry to understand spine tumors and disorders

Duke Spine Outcome Study (DSOS)

This study is trying to learn more about spine tumors and disorders by collecting health information and samples from patients with these conditions and comparing them to those having spine surgery for other reasons.

Quick facts

• Study type: Observational
• Enrollment: 900 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Duke University (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT04217525 on ClinicalTrials.gov

What this trial studies

This registry aims to enhance knowledge about spinal tumors and disorders to inform future management strategies. It involves reviewing medical records, collecting health-related quality of life data, and obtaining tissue and sample specimens during surgeries. Patients diagnosed with spinal tumors, infections, instability, or injuries will be included, and samples such as blood and bone marrow will be collected. The study will also include a control group of patients undergoing spine surgery without concurrent cancer diagnoses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with a diagnosis of spinal tumors, infections, instability, or injuries.

Not a fit: Patients with a history of substance abuse or concurrent cancer diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with spinal tumors and disorders.

How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown success in enhancing understanding of spinal conditions.

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.

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Courtney R. Goodwin, M.D., PhD — Duke University
• Study coordinator: Coutney E Wimberly

Conditions: Spinal Tumor, Spinal Disorder