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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02790983
Ethics application status
Date submitted
18/05/2016
Date registered
6/06/2016
Date last updated
13/08/2020

Titles & IDs
Public title
Primary Tumor Research and Outcome Network
Scientific title
Primary Tumor Research and Outcome Network (PTRON) A Multicenter Prospective Registry for the Management 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 - For every follow-up visit, each patient will be assessed in terms of their survival status. If death is known, no further action is required. If the patient's status is "alive" and the last follow-up visit is older than 3 months, a cross-sectional assessment of the current status will be performed for the follow-up visit.
Cross-sectional survival data: Patients whose status at last follow-up was classified as "alive" will be included in the cross-sectional data collection set. This procedure should ensure that vital status data of all patients are complete and updated in order to perform a valid overall survival analysis. Medical charts will be the primary source used to determine the current vital status of the study patients. If the participating investigational sites have access to individual patient data through an official vital statistics, they may revert to this option or by contacting the patient's family doctor, the patient, or the patient's relatives.
Timepoint [1] 0 0
Every standard of care scheduled follow-up visit up to 3 years
Primary outcome [2] 0 0
Local disease recurrence data - For every follow-up visit, each patient, regardless of which stage they are at in their treatment will be evaluated for local disease recurrence. Presence or absence of a local recurrence and distant metastases should be confirmed through imaging. The analysis will be performed in accordance with local standard of care scheduled follow-up visits.
Timepoint [2] 0 0
Every standard of care scheduled follow-up visit up to 3 years
Primary outcome [3] 0 0
Perioperative morbidity data - Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up.
Intraoperative complications: (Airway/ventilation; Allergic reaction; Anesthesia related; Bone implant interface failure requiring revision; Cardiac; Cord injury; Dural tear; Hardware malposition requiring revision; Hypotension ; Massive blood loss ; Nerve root injury; Pressure sores; Vascular injury; Visceral injury; Other).
Pre-/post treatment complications: (Cardiac arrest/failure/arrhythmia; Construct failure with loss of correction; Construct failure without loss of correction; CSF leak/meningocele; Deep vein thrombosis; Deep wound infection; Delirium; Dysphagia; Dysphonia; GI bleeding; Hematoma; Myocardial infarction; Neurologic deterioration; Non-union; Pneumonia; Postoperative neuropathic pain; Pressure sores; Pulmonary embolism; Superficial wound infection; Systemic infection; Urinary tract infection; Wound dehiscence; Other)
Timepoint [3] 0 0
Every standard of care scheduled follow-up visit up to 3 years
Secondary outcome [1] 0 0
Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) - The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status.
EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
Timepoint [1] 0 0
Every standard of care scheduled follow-up visit up to 3 years
Secondary outcome [2] 0 0
Pain Numeric Rating Scale - It will be assessed for neck, back, leg and arm. The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.
Timepoint [2] 0 0
Every standard of care scheduled follow-up visit up to 3 years
Secondary outcome [3] 0 0
SF-36 version 2 - It is a multipurpose, short-form health survey with 36 questions. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS). A scoring algorithm is available using linear T-score transformation that translates scores using population based norms into scores with mean = 50 and standard deviation = 10. The algorithm is available for all 8 subscales as well for the PCS and MCS.
Timepoint [3] 0 0
Every standard of care scheduled follow-up visit up to 3 years
Secondary outcome [4] 0 0
Spine Oncology Study Group Outcome Questionnaire - This is a new HRQOL outcome tool which was developed specifically for metastatic spine disease. It is currently available in English and Hungarian. It contains 56 concepts representing all four domains of the International Classification of Function and Disability. It is made up of five domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the SF-36 for patients with spine tumors.
Timepoint [4] 0 0
Every standard of care scheduled follow-up visit up to 3 years

Eligibility
Key inclusion criteria
- Patient diagnosed with a primary tumor of the spine who receive medical and/or
surgical treatment for the tumor.

- Patient willing and able to participate in the registry and able to attend follow-up
visits, according to the investigator.

- Patient capable of understanding the content of the patient information and Informed
Consent Form (if consent is required by the EC/ IRB at the registry site).

- Patient who has agreed to participate in the registry by providing consent according
to the applicable local law and the declaration of Helsinki.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient diagnosed with a metastatic tumor of the spine.

- Patient diagnosed with a primary spinal cord tumor.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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 Clinical Investigation and Publishing Documentation
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
Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients
will be collected and evaluated to investigate the prognostic factors which influence
survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups
of patients diagnosed with primary spinal column tumors.
Trial website
https://clinicaltrials.gov/show/NCT02790983
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charles G. Fisher, MD
Address 0 0
Professor and Head
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Severine Hurni, Dr.
Address 0 0
Country 0 0
Phone 0 0
+41 81 414 25 09
Fax 0 0
Email 0 0
severine.hurni@aofoundation.org
Contact person for scientific queries

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