Primary Tumor Research and Outcomes Network
- Conditions
- Spinal Column Tumor
- Registration Number
- NCT02790983
- Lead Sponsor
- AO Innovation Translation Center
- 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.
- Detailed Description
Objective: To prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with:
* survival
* 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
* Symptoms
* 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1350
Not provided
- Patient diagnosed with a metastatic tumor of the spine.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perioperative morbidity data 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)Local disease recurrence data 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.
Overall survival data 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
- Secondary Outcome Measures
Name Time Method Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) 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 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.
Spine Oncology Study Group Outcome Questionnaire 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 satisfaction 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.
SF-36 version 2 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.
Survey on patient expectation Prior to surgical treatment A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.
Trial Locations
- Locations (19)
Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden
🇩🇪Dresden, Germany
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Queensland, School of Medicine
🇦🇺Brisbane, Australia
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
IRCCS Istituto Ortopedico Galeazzi
🇮🇹Milano, Italy
University of California
🇺🇸Los Angeles, California, United States
Kanazawa Medical University Hospital
🇯🇵Kanazawa, Japan
Oxford University Hospitals
🇬🇧Oxford, United Kingdom
Peking University 3rd Hospital
🇨🇳Beijing, Beijing, China
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
National Center for Spinal Disorders and Buda Health Center
ðŸ‡ðŸ‡ºBudapest, Hungary
Vancouver General Hospital and the University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States