Duke Spine Outcome Study (DSOS)

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Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04217525
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Duke University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Courtney R. Goodwin, M.D., PhD
Principal Investigator Affiliation	Duke University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Tumor, Spinal Disorder

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Courtney E Wimberly

[email protected]

919-681-9609