Duke Spine Outcome Study (DSOS)

Last updated: September 11, 2024
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Disorders

Spinal Cord Malignancy

Treatment

N/A

Clinical Study ID

NCT04217525
Pro00101198
  • Ages 18-85
  • All Genders

Study 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

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 theauspices of the neurosurgery program.

  • No concurrent cancer diagnosis.

  • Accessibility for treatment and follow up.

  • Patient consent obtained according to Duke institutional policy.

Exclusion

Exclusion Criteria:

  • History of substance abuse (recreational drugs, alcohol) within 12 months prior toscreening

  • Is a prisoner.

  • A disease or condition that would, in opinion of the investigator, preclude accurateevaluation

(e.g. significant psychiatric disease), or that would impair the ability of thepatient to receive protocol treatment or comply with protocol.

  • Pregnant or breast feeding during the study period (women of child-bearing potentialwill 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 limitedto diagnosed lymphomas, leukemias, sickle cell or other anemias not associated withtheir current condition.

  • Polycythemia vera.

  • Known or suspected immunodeficiency or Human Immunodeficiency Virus (HIV).

  • Hematocrit < 24% pre-operatively.

Study Design

Total Participants: 900
Study Start date:
December 03, 2019
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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