Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients will be collected and evaluated to investigate the prognostic factors which influence survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups of patients diagnosed with primary spinal column tumors.

Official Title

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

Details

Objective: To prospectively investigate the prognostic variables (clinical, diagnostic, and therapeutic) within subgroups of patients diagnosed with primary spinal column tumors that are associated with:

  • survival
  • local recurrence
  • perioperative morbidity
  • 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

The investigators aim to collect the following outcome measures:

  • Overall survival data
  • Local disease recurrence data
  • Perioperative morbidity data

Patient reported outcomes:

  • Euroqual-5D-3L
  • 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

Keywords

Spinal Column Tumor Registry Spine Surgery Medical Oncology Radiation Oncology Neoplasms

Eligibility

You can join if…

  • Patient diagnosed with a primary tumor of the spine who receive medical and/or surgical treatment for the tumor.
  • Patient willing and able to participate in the registry and able to attend follow-up visits, according to the investigator.
  • Patient capable of understanding the content of the patient information and Informed Consent Form (if consent is required by the EC/ IRB at the registry site).
  • Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.

You CAN'T join if...

  • Patient diagnosed with a metastatic tumor of the spine.
  • Patient diagnosed with a primary spinal cord tumor.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California CA 94134 United States
  • Vancouver General Hospital and the University of British Columbia accepting new patients
    Vancouver British Columbia V5Z 1M9 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AO Clinical Investigation and Documentation
ID
NCT02790983
Study Type
Observational [Patient Registry]
Last Updated