Duke Spine Outcome Study (DSOS) (DSOS)

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Tumor; Spinal Disorder

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Coutney E Wimberly; Phone Number: 919-681-9609; Email: courtney.wimberly@duke.edu
• Study Contact Backup: Name: Beth Perry, RN; Phone Number: 919-681-2695; Email: beth.perry@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Courtney E Wimberly; Phone Number: 919-681-9609; Email: courtney.wimberly@duke.edu
      • Principal Investigator: Courtney R. Goodwin, M.D., PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal disorders or spinal tumors.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Spinal Disorders; This group includes patients with any spinal deformity or disorder coming in for treatment.
Spinal Tumors; This group includes patients with spinal tumors or metastasis of the spine, coming in for treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)	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.	Baseline, 6, 12, 26, 52, 104 weeks
Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)	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.	Baseline, 6, 12, 26, 52, 104 weeks
Change in Quality of Life as measured by SF-36 version 2	Short-form health survey with 36 questions	Baseline, 6, 12, 26, 52, 104 weeks
Change in Health Status as measured by EQ-5D	It contains 5 questions and provides a simple descriptive profile and a single index value for health status.	Baseline, 6, 12, 26, 52, 104 weeks
Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status	Grade 0 = Fully active to 5 = Dead	Baseline, 6, 12, 26, 52, 104 weeks
Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)	ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit.	Baseline, 6, 12, 26, 52, 104 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Courtney R. Goodwin, M.D., PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Bone Diseases; Bone Neoplasms; Spinal Diseases; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: Pro00101198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No