Primary Tumor Research and Outcomes Network
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spinal Column Tumor. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, China, Germany +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
Overview
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
Primary outcome measures
- Overall survival data [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
- Local disease recurrence data [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
- Perioperative morbidity data [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
Secondary outcome measures (6)
- Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
- Pain Numeric Rating Scale [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
- SF-36 version 2 [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
- Spine Oncology Study Group Outcome Questionnaire [Time frame: From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years]
- Survey on patient expectation [Time frame: Prior to surgical treatment]
- Survey on patient satisfaction [Time frame: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 9 centers
- University of California — Los Angeles
- UCSF Medical Center — San Francisco
- Johns Hopkins University School of Medicine — Baltimore
- Massachusetts General Hospital — Boston
- Mayo Clinic — Rochester
- Memorial Sloan-Kettering Cancer Center — New York
- Memorial Sloan Kettering Cancer Center — New York
- Rhode Island Hospital — Providence
- … and 1 more center
Canada · 2 centers
- Vancouver General Hospital and the University of British Columbia — Vancouver
- Toronto Western Hospital — Toronto
Italy · 2 centers
- Istituto Ortopedico Rizzoli — Bologna
- IRCCS Istituto Ortopedico Galeazzi — Milan
Australia · 1 center
- University of Queensland, School of Medicine — Brisbane
China · 1 center
- Peking University 3rd Hospital — Beijing
Germany · 1 center
- Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden — Dresden
Hungary · 1 center
- National Center for Spinal Disorders and Buda Health Center — Budapest
Japan · 1 center
- Kanazawa Medical University Hospital — Kanazawa
United Kingdom · 1 center
- Oxford University Hospitals — Oxford
Identifiers
NCT: NCT02790983 · PTRON