Primary Tumor Research and Outcomes Network

NCT02790983 | Recruiting

• 1 other identifier: PTRON
• Study Type: observational
• Target: 1,350
• Locations: 9 countries
• Sites: 19

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.

Conditions

Spinal Column Tumor

Keywords

Registry; Spine; Surgery; Medical Oncology; Radiation Oncology; Neoplasms; Systemic Oncologic Therapy; Radiation Therapy; Tumor Markers

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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)

  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 Outcomes (6)

• 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

• 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

• 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

• 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

• Survey on patient expectation

  Prior to surgical treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a primary tumor of the spine or patients with a history of a spine tumor

You may qualify if:

• Patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and/or spinal cord. This includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.).
• Informed consent obtained, i.e.:
• Ability to understand the content of the patient information/ICF
• Willingness and ability to participate in the registry according to the Registry Plan (RP)
• Signed and dated EC/IRB approved written informed consent
• Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

You may not qualify if:

• \- Patient diagnosed with a metastatic tumor of the spine.

Sponsors & Collaborators

• AO Innovation Translation Center: lead
• AO Foundation, AO Spine: collaborator

Study Sites (19)

University of California

Los Angeles, California, 90095, United States

TERMINATED

UCSF Medical Center

San Francisco, California, 94134, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

WITHDRAWN

Memorial Sloan Kettering Cancer Center

New York, New York, 1275, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Queensland, School of Medicine

Brisbane, 4000 QLD, Australia

WITHDRAWN

Vancouver General Hospital and the University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

TERMINATED

Peking University 3rd Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden

Dresden, 1307, Germany

RECRUITING

National Center for Spinal Disorders and Buda Health Center

Budapest, 1126, Hungary

RECRUITING

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Kanazawa Medical University Hospital

Kanazawa, 920-8641, Japan

TERMINATED

Oxford University Hospitals

Oxford, OX3 7HE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue and adjacent normal tissue Blood

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeremy Reynolds, MD

  Clinical Lead for Spinal Surgery at Oxford University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Thomas, PhD

CONTACT

+41 79 671 47 98; felix.thomas@aofoundation.org

Mariana Cabeleira

CONTACT

+41 79 671 47 98; mariana.cabeleira@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 6, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); US (9); AU (1); CA (2); GB (1); CN (1); DE (1); JP (1); IT (2)