Primary Tumor Research and Outcomes Network (PTRON)
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|ClinicalTrials.gov Identifier: NCT02790983|
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : July 20, 2022
|Condition or disease|
|Spinal Column Tumor|
Objective: To prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with:
- local recurrence
- morbidity data
- 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
We aim to collect the following outcome measures:
- Overall survival data
- Local disease recurrence data
- Morbidity data
- Patient reported outcomes:
- Euroquol-5D-3L, EQ-5D-Y (if applicable)
- 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 (SOSGOQ) v1.0 and v2.0
- Surverys on patient expectations and satisfaction
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1350 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes 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: 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 ]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
- Local disease recurrence data [ Time Frame: 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 ]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.
- Perioperative morbidity data [ Time Frame: 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 ]
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: 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 ]
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: 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 ]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: 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 ]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: 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 ]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
- Survey on patient expectation [ Time Frame: Prior to surgical treatment ]A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.
- Survey on patient satisfaction [ Time Frame: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years ]A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.
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 Bender, Dr.||+41 78 634 19 email@example.com|
|Principal Investigator:||Jeremy Reynolds, MD||Clinical Lead for Spinal Surgery at Oxford University Hospitals|