Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
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
Outcome measures
Primary
Overall survival data
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
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
Local disease recurrence data
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.
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
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)
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
Secondary
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
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
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
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
Survey on patient expectation
Time frame: Prior to 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
Eligibility criteria
Study locations (9)
University of California
Los Angeles, California, 90095
UCSF Medical Center
San Francisco, California, 94134
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mayo Clinic
Rochester, Minnesota, 55905
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 1275
Rhode Island Hospital
Providence, Rhode Island, 02903
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030