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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02830451




Registration number
NCT02830451
Ethics application status
Date submitted
21/06/2016
Date registered
12/07/2016

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

Health condition
Health condition(s) or problem(s) studied:
Metastatic Spine 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
Patient details
Timepoint [1] 0 0
collected at baseline
Primary outcome [2] 0 0
Tumor details
Timepoint [2] 0 0
collected at baseline, first prospective treatment and follow-up
Primary outcome [3] 0 0
Symptoms
Timepoint [3] 0 0
collected at baseline, first prospective treatment and follow-up
Primary outcome [4] 0 0
Treatment details - previous treatment of the index of the spine
Timepoint [4] 0 0
Collected at baseline
Primary outcome [5] 0 0
Imaging information
Timepoint [5] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [6] 0 0
Patient reported outcomes - Euroqol EQ-5D-3L / - EQ-5D VAS
Timepoint [6] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [7] 0 0
Ambulation
Timepoint [7] 0 0
collected at baseline, discharge and at follow-up.
Primary outcome [8] 0 0
Nutritional status tool
Timepoint [8] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [9] 0 0
Morbidity data - Adverse events
Timepoint [9] 0 0
collected at first prospective treatment, discharge and at follow-up.
Primary outcome [10] 0 0
Local disease recurrence data
Timepoint [10] 0 0
collected at baseline and at follow-up.
Primary outcome [11] 0 0
Survival
Timepoint [11] 0 0
collected at first prospective treatment, discharge and at follow-up.
Primary outcome [12] 0 0
Treatment details - Current treatment of the index target of the spine
Timepoint [12] 0 0
collected at first prospective treatment and at follow-up.
Primary outcome [13] 0 0
Treatment details - Current treatment for the primary cancer
Timepoint [13] 0 0
collected at baseline, first prospective treatment and at follow-up.
Primary outcome [14] 0 0
Patient reported outcomes - Pain Numeric Rating Scale
Timepoint [14] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [15] 0 0
Patient reported outcomes - Spine Oncology Study Group Outcome Questionnaire (SOSGOQ)
Timepoint [15] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Secondary outcome [1] 0 0
Symptoms: American Spinal Injury Association (ASIA) Impairment Scale
Timepoint [1] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Secondary outcome [2] 0 0
Symptoms: Eastern Cooperative Oncology Group (ECOG) classification
Timepoint [2] 0 0
collected at baseline, first prospective treatment, and at follow-up.
Secondary outcome [3] 0 0
Symptoms: Epidural Compression Classification
Timepoint [3] 0 0
Collected at baseline
Secondary outcome [4] 0 0
Spine Instability Neoplastic Score (SINS)
Timepoint [4] 0 0
collected at baseline and first prospective treatment,

Eligibility
Key inclusion criteria
* Patient 18 or older.
* Patient diagnosed with a metastatic tumor of the spine
* 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
* Signed and dated EC/IRB approved written informed consent (if consent is required by the EC/ IRB at the registry site)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient diagnosed with a primary 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
15/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
960
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University Melbourne - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
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
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Manitoba
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Germany
State/province [14] 0 0
Sachsen
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Italy
State/province [16] 0 0
Emilia-Romagna
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardei
Country [18] 0 0
Japan
State/province [18] 0 0
Ishikawa
Country [19] 0 0
Netherlands
State/province [19] 0 0
Utrecht
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Switzerland
State/province [21] 0 0
Basel

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charles G. Fisher, MD
Address 0 0
Vancouver General Hospital and the University of British Columbia
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
benjamin.bretzinger@aofoundation.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02830451