Primary Tumor Research and Outcomes Network (PTRON)
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- STATUS
- Recruiting
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- End date
- Dec 27, 2023
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- participants needed
- 1350
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- sponsor
- AO Innovation Translation Center
Summary
This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.
Description
Objective: To prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with:
- survival
- local recurrence
- morbidity data
- patient reported outcomes
Outcome measures: Variables applicable to primary spinal column tumor patients which will be collected in the registry include:
- Patient details
- Treatment status
- Details of previous treatment
- Diagnosis and biopsy types
- Tumor details
- Oncological staging
- Symptoms
- Treatment details
- Imaging information
We aim to collect the following outcome measures:
- Overall survival data
- Local disease recurrence data
- Morbidity data
- Patient reported outcomes:
- Euroquol-5D-3L, EQ-5D-Y (if applicable)
- Euroquol EQ-5D VAS - Quality of Life
- Neck pain numeric rating scale (NRS)
- Arm pain NRS
- Back pain NRS
- Leg Pain NRS
- SF-36 version 2
- SOSG Outcome Questionnaire (SOSGOQ) v1.0 and v2.0
- Surverys on patient expectations and satisfaction
Details
| Condition | Spinal Column Tumor |
|---|---|
| Clinical Study Identifier | NCT02790983 |
| Sponsor | AO Innovation Translation Center |
| Last Modified on | 4 October 2022 |
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