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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
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Secondary ID [1]
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PTRON
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Universal Trial Number (UTN)
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Trial acronym
PTRON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Column Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival data
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Assessment method [1]
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FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive
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Timepoint [1]
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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
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Primary outcome [2]
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Local disease recurrence data
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Assessment method [2]
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At first prospective treatment and every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease recurrence. Patients that are classified as "non-virgin" will be evaluated for local disease recurrence also at baseline.
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Timepoint [2]
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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
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Primary outcome [3]
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Perioperative morbidity data
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Assessment method [3]
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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)
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Timepoint [3]
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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
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Secondary outcome [1]
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Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y)
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [2]
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Pain Numeric Rating Scale
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Assessment method [2]
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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.
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Timepoint [2]
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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
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Secondary outcome [3]
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SF-36 version 2
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Assessment method [3]
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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.
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Timepoint [3]
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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
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Secondary outcome [4]
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Spine Oncology Study Group Outcome Questionnaire
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Assessment method [4]
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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 20 items representing all four domains of the International Classification of Function and Disability. Additionally, there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health, and social function. During the first phase of this registry, patients completed the SOSGOQ version 1.0. The English SOSGOQ version 2.0 was released in January 2018 and will be used
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Timepoint [4]
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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
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Secondary outcome [5]
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Survey on patient expectation
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Assessment method [5]
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A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.
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Timepoint [5]
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Prior to surgical treatment
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Secondary outcome [6]
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Survey on patient satisfaction
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Assessment method [6]
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A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.
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Timepoint [6]
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After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years
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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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient diagnosed with a metastatic tumor of the spine.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
1350
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of Queensland, School of Medicine - Brisbane
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Recruitment postcode(s) [1]
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4000 QLD - Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Minnesota
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Rhode Island
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Canada
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State/province [8]
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British Columbia
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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China
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State/province [10]
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Beijing
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Country [11]
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Germany
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State/province [11]
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Dresden
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Country [12]
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Hungary
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State/province [12]
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Budapest
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Country [13]
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Italy
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State/province [13]
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Bologna
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Country [14]
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Italy
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State/province [14]
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Milano
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Country [15]
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Japan
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State/province [15]
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Kanazawa
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Country [16]
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United Kingdom
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State/province [16]
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Oxford
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Funding & Sponsors
Primary sponsor type
Other
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Name
AO Innovation Translation Center
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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AO Foundation, AO Spine
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02790983
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jeremy Reynolds, MD
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Address
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Clinical Lead for Spinal Surgery at Oxford University Hospitals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Benjamin Bretzinger
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Address
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Country
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Phone
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+41 79 814 01 48
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02790983
Download to PDF