Spine Oncology Registry

A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Metastases; Spine Cancer; Spine Tumor

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Allison Garvin; Email: NeurosurgerySpineResearch@osumc.edu
• Study Contact Backup: Name: Courtney Wright; Phone Number: 6142934876; Email: Courtney.Wright@osumc.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • University of Michigan
      • Contact: Nicholas Szerlip
      • Principal Investigator: Nicholas Szerlip, MD
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Not yet recruiting
      • Rutgers Robert Wood Johnson Medical School
      • Contact: Christine Yohn
      • Principal Investigator: Jonathan Sherman, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical CEnter
      • Contact: Allison Garvin
      • Principal Investigator: Brad Elder, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of patients with primary and metastatic spine disease who undergo surgery followed by radiation therapy.

Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in this registry.

Patients may be enrolled regardless of other current local or systemic treatments of disease extent.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		12, 18, 24 months
Local control of treated lesion based on radiographic review	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	3, 6, 9, 12, 15, 16, 21, 24 months
Progression free survival		3, 6, 9, 12, 15, 16, 21, 24 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Icotec Medical, Inc
• Investigators: Principal Investigator: James B Elder, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

• First Submitted: October 14, 2025
• First Submitted That Met QC Criteria: November 5, 2025
• First Posted (Estimated): November 6, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Diseases; Spinal Cord Neoplasms
• Other Study ID Numbers: 20253216; NCI-2024-07629 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); OSU-23207 (Other Identifier: Ohio State University Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No