Summary

Location
at UCLA UCSF
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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

Keywords

Spinal Column Tumor, Registry, Spine, Surgery, Medical Oncology, Radiation Oncology, Neoplasms, Systemic Oncologic Therapy, Radiation Therapy, Tumor Markers

Eligibility

You can join if…

  • Patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and/or spinal cord. This includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.).
  • Informed consent obtained, i.e.:
    • Ability to understand the content of the patient information/ICF
    • Willingness and ability to participate in the registry according to the Registry Plan (RP)
    • Signed and dated EC/IRB approved written informed consent

      OR

  • Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

You CAN'T join if...

- Patient diagnosed with a metastatic tumor of the spine.

Locations

  • University of California in progress, not accepting new patients
    Los Angeles California 90095 United States
  • UCSF Medical Center accepting new patients
    San Francisco California 94134 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AO Innovation Translation Center
ID
NCT02790983
Study Type
Observational [Patient Registry]
Participants
Expecting 1350 study participants
Last Updated