NCT07225491

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
142mo left

Started Nov 2025

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Nov 2025Dec 2037

First Submitted

Initial submission to the registry

October 14, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

November 24, 2025

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

10.1 years

First QC Date

October 14, 2025

Last Update Submit

December 14, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Rutgers Robert wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • James B Elder, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2025

First Posted

November 6, 2025

Study Start

November 24, 2025

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2037

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations