Primary Tumor Research and Outcome Network (PTRON)
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|ClinicalTrials.gov Identifier: NCT02790983|
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : October 30, 2019
|Condition or disease|
|Spinal Column Tumor|
Objective: To prospectively investigate the prognostic variables (clinical, diagnostic, and therapeutic) within subgroups of patients diagnosed with primary spinal column tumors that are associated with:
- local recurrence
- perioperative morbidity
- 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
- Treatment details
- Imaging information
The investigators aim to collect the following outcome measures:
- Overall survival data
- Local disease recurrence data
- Perioperative morbidity data
Patient reported outcomes:
- 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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1350 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Primary Tumor Research and Outcome Network (PTRON) A Multicenter Prospective Registry for the Management of Primary Tumors of the Spine|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
- Overall survival data [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
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.
- Local disease recurrence data [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]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.
- Perioperative morbidity data [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
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)
- Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]
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.
- Pain Numeric Rating Scale [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]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.
- SF-36 version 2 [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]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.
- Spine Oncology Study Group Outcome Questionnaire [ Time Frame: Every standard of care scheduled follow-up visit up to 3 years ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790983
|Contact: Severine Hurni, Dr.||+41 81 414 25 email@example.com|
|Principal Investigator:||Charles G. Fisher, MD||Professor and Head|