Primary Tumor Research and Outcomes Network (PTRON)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    1350
  • sponsor
    AO Innovation Translation Center
Updated on 4 October 2022

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 IdentifierNCT02790983
SponsorAO Innovation Translation Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note