NCT02790983

Primary Tumor Research and Outcomes Network

Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,350 (estimated)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Spinal Column Tumor

Timeline

• Start date: 2016-10-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2016-06-06
• Last updated: 2026-02-25

Locations

19 sites across 9 countries: United States, Australia, Canada, China, Germany, Hungary, Italy, Japan, United Kingdom