SUSPENDED

Duke Spine Outcome Study (DSOS)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Duke Spine Outcome Study (DSOS)

Quick Facts

Study Start:2019-12-03

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT04217525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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 * 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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
* 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.

Contacts and Locations

Principal Investigator

Courtney R. Goodwin, M.D., PhD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Courtney R. Goodwin, M.D., PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-03

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2019-12-03

Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

Spinal Tumor
Spinal Disorder