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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02790983




Registration number
NCT02790983
Ethics application status
Date submitted
18/05/2016
Date registered
6/06/2016
Date last updated
20/03/2024

Titles & IDs
Public title
Primary Tumor Research and Outcomes Network
Scientific title
Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
Secondary ID [1] 0 0
PTRON
Universal Trial Number (UTN)
Trial acronym
PTRON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Column Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival data
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Local disease recurrence data
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Perioperative morbidity data
Timepoint [3] 0 0
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 [1] 0 0
Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y)
Timepoint [1] 0 0
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 [2] 0 0
Pain Numeric Rating Scale
Timepoint [2] 0 0
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 [3] 0 0
SF-36 version 2
Timepoint [3] 0 0
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 [4] 0 0
Spine Oncology Study Group Outcome Questionnaire
Timepoint [4] 0 0
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 [5] 0 0
Survey on patient expectation
Timepoint [5] 0 0
Prior to surgical treatment
Secondary outcome [6] 0 0
Survey on patient satisfaction
Timepoint [6] 0 0
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
Key inclusion 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient diagnosed with a metastatic tumor of the spine.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
1350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Queensland, School of Medicine - Brisbane
Recruitment postcode(s) [1] 0 0
4000 QLD - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Rhode Island
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Italy
State/province [13] 0 0
Bologna
Country [14] 0 0
Italy
State/province [14] 0 0
Milano
Country [15] 0 0
Japan
State/province [15] 0 0
Kanazawa
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Other
Name
AO Innovation Translation Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
AO Foundation, AO Spine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02790983
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeremy Reynolds, MD
Address 0 0
Clinical Lead for Spinal Surgery at Oxford University Hospitals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Benjamin Bretzinger
Address 0 0
Country 0 0
Phone 0 0
+41 79 814 01 48
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02790983