Primary Tumor Research and Outcomes Network

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• 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.
• 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)

Trial sites (19)