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Duke Spine Outcome Study (DSOS) (DSOS)

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ClinicalTrials.gov Identifier: NCT04217525
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease
Spinal Tumor Spinal Disorder

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Duke Spine Outcome Study (DSOS)
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ) [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]
    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.

  2. Change in Pain Score as measured by Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]
    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.

  3. Change in Quality of Life as measured by SF-36 version 2 [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]
    Short-form health survey with 36 questions

  4. Change in Health Status as measured by EQ-5D [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]
    It contains 5 questions and provides a simple descriptive profile and a single index value for health status.

  5. Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]
    Grade 0 = Fully active to 5 = Dead

  6. Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: Baseline, 6, 12, 26, 52, 104 weeks ]
    ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit.


Biospecimen Retention:   Samples With DNA
Will collect up to 60mL of blood and 5mL of bone marrow.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with spinal disorders or spinal tumors.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217525


Contacts
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Contact: Alexia Bwensa 919-681-5484 alexia.bwensa@duke.edu
Contact: Beth Perry, RN 919-681-2695 beth.perry@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Alexia Bwensa    919-681-5484    alexia.bwensa@duke.edu   
Principal Investigator: Courtney R. Goodwin, M.D., PhD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Courtney R. Goodwin, M.D., PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04217525    
Other Study ID Numbers: Pro00101198
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Neoplasms
Spinal Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases