Spine Oncology Registry

Not yet recruiting

• Conditions: Spine Tumor; Spine Metastases; Spine Cancer

• Registration Number: NCT07225491
• Lead Sponsor: Ohio State University

Brief Summary

This is an observational study to evaluate hardware related and oncologic outcomes in adult patients with primary and metastatic spine disease undergoing separation surgery followed by radiation treatment.

Detailed Description

This study is being done to collect information about patients undergoing separation surgery followed by radiation for the treatment of primary and metastatic spine disease. Participants will be asked to complete some patient reported outcome questionnaires and researchers will collect information from medical records to evaluate oncologic and hardware related outcomes.

Study Timeline

• Study First Submitted: 2025-10-14
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-05
• Last Update Submitted: 2025-11-05
• Study First Posted: 2025-11-06
• Last Update Posted: 2025-11-06
• Study Start: 2025-12-01
• Primary Completion: 2035-12-31
• Study Completion: 2037-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	12, 18, 24 months
Local control of treated lesion based on radiographic review	3, 6, 9, 12, 15, 16, 21, 24 months	Patients will be classified as achieving local control if demonstrating response of treated spine lesion after treatment. Local control will be assessed by comparing the radiographic images after treatment and prospectively every 3 months for up to 24 months
Progression free survival	3, 6, 9, 12, 15, 16, 21, 24 months

Trial Locations

Locations (3)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Rutgers Robert wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States