Spine TumorNCT07225491
Spine Oncology Registry
An observational study of Spine Tumor and Spine Metastases, run by Ohio State University Comprehensive Cancer Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Tumor, Spine Metastases, Spine Cancer
- How many people
- 3,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Nov 2025to 31 Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Allison Garvin contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Nicholas Szerlip
Nicholas Szerlip, MD
- Recruiting
University of Maryland,
Baltimore, Maryland, 21201
Amber Stewart
Timothy Chryssikos, MD
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Allison Garvin
Brad Elder, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Marissa Lowe
Matthew Pease, MD
- Recruiting
Rutgers Robert wood Johnson Medical School
New Brunswick, New Jersey, 08901
Christine Yohn
Jonathan Sherman, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Spine Tumor, Spine Metastases, Spine Cancer
- Medical subject headings
- Spinal Cord Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 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
Measured: 3, 6, 9, 12, 15, 16, 21, 24 months
Progression free survival
Measured: 3, 6, 9, 12, 15, 16, 21, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start24 Nov 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Icotec Medical, Inc
- Responsible party
- Principal investigator, James Elder, Ohio State University Comprehensive Cancer Center
- Investigators
- James B Elder, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225491
- Sponsor's protocol ID
- 20253216
- Other IDs
- NCI-2024-07629, OSU-23207
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors
- ClinicalTrials.gov ID
- NCT07225491
- Acronym / sponsor ID
- 20253216
- Conditions
- Spine Tumor, Spine Metastases, Spine Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Icotec Medical, Inc
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 12, 18, 24 months
Local control of treated lesion based on radiographic review
Time frame: 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
Time frame: 3, 6, 9, 12, 15, 16, 21, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Garvin contact
James B Elder, MD principal investigator
Ohio State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Tumor and Spine Metastases, run by Ohio State University Comprehensive Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Wright (614-293-4876, Courtney.Wright@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 12, 18, 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.