ClinicalTrials.Veeva

Menu

Primary Tumor Research and Outcomes Network (PTRON)

A

AO Innovation Translation Center

Status

Enrolling

Conditions

Spinal Column Tumor

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

1,350 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • 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

Exclusion Criteria:

  • Patient diagnosed with a metastatic tumor of the spine.

Trial contacts and locations

19

Loading...

Central trial contact

Felix Thomas; Benjamin Bretzinger

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems