Spine tumor registry tracking outcomes after separation surgery and radiation
A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors
Ohio State University Comprehensive Cancer Center · NCT07225491
This registry will collect information to see what outcomes adults with primary or metastatic spine tumors have after separation surgery followed by radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Ann Arbor, Michigan and 2 other locations) |
| Trial ID | NCT07225491 on ClinicalTrials.gov |
What this trial studies
This observational registry collects clinical data and patient-reported outcomes from adults with primary or metastatic spine tumors who undergo separation surgery followed by postoperative radiation. Investigators will extract operative details, hardware status, imaging and radiation dosimetry, oncologic outcomes, and adverse events from medical records. Participants will complete standardized questionnaires on pain, function, and quality of life over time. The multi-center design across academic sites aims to describe hardware-related complications and local tumor control without assigning experimental treatments.
Who should consider this trial
Good fit: Adults with primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation treatment and who can undergo standard MRI or CT-based planning are the ideal candidates.
Not a fit: Children, patients who will not receive radiation or cannot undergo standard MRI/CT planning, and people not having separation surgery are unlikely to benefit from this registry.
Why it matters
Potential benefit: If successful, the registry could help surgeons and radiation teams choose surgical and implant strategies and radiation plans that reduce hardware failures and improve local tumor control and patient-reported outcomes.
How similar studies have performed: Previous observational series and registries of separation surgery followed by stereotactic or conventional radiation have reported useful data on hardware complication rates and local control, so this approach builds on existing, partly successful evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy Exclusion Criteria: * Inability to obtain a standard MRI or CT / CT myelogram for radiation treatment planning and dosimetry * Inability to receive radiation treatment. * Patients under 18 years of age
Where this trial is running
Ann Arbor, Michigan and 2 other locations
- University of Michigan — Ann Arbor, Michigan, United States (NOT_YET_RECRUITING)
- Rutgers Robert wood Johnson Medical School — New Brunswick, New Jersey, United States (NOT_YET_RECRUITING)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: James B Elder, MD — Ohio State University
- Study coordinator: Courtney Wright
- Email: Courtney.Wright@osumc.edu
- Phone: 6142934876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spine Tumor, Spine Metastases, Spine Cancer