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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-07629 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| OSU-23207 | Other Identifier | Ohio State University Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Icotec Medical, Inc | UNKNOWN |
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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.
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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Wright | Contact | 6142934876 | Courtney.Wright@osumc.edu | |
| Allison Garvin | Contact | NeurosurgerySpineResearch@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| James B Elder, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Rutgers Robert wood Johnson Medical School | Not yet recruiting | New Brunswick | New Jersey | 08901 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |