Duke Spine Outcome Study (DSOS)

Spinal Tumor Clinical Trial

— DSOS  

Official title:

Duke Spine Outcome Study (DSOS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217525
• Other study ID #: Pro00101198
• Status: Recruiting
• Start date: December 3, 2019
• Est. completion date: December 1, 2026

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: Coutney E Wimberly
• Phone: 919-681-9609
• Email: courtney.wimberly[@]duke.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Neoplasms
• Spinal Diseases
• Spinal Disorder
• Spinal Neoplasms
• Spinal Tumor

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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