Spinal Column TumorPTRONNCT02790983
Primary Tumor Research and Outcomes Network
An observational study of Spinal Column Tumor, run by AO Innovation Translation Center at 19 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Column Tumor
- How many people
- 1,350 participants
- Where
- 19 sitesin 9 countries
- Study dates
- Oct 2016to Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with a primary tumor of the spine or patients with a history of a spine tumor
Who may be able to join
- 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
- OR
- Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
Who cannot join
- Patient diagnosed with a metastatic tumor of the spine.
Trial locations and contacts
19 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 9 countries
United States9 sites, 7 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Chetan Bettegowda, MD, cbetteg1@jhmi.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
John H Shin, MD, Shin.John@mgh.harvard.edu
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Laurence D. Rhines, MD, lrhines@mdanderson.org
- Terminated
University of California
Los Angeles, California, 90095
- Withdrawn
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 1275
Ori Barilai, MD, barzilao@mskcc.org
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Ziya L. Gokaslan, MD, ziya_gokaslan@brown.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Michelle Clarke, MD, Clarke.Michelle@mayo.edu
- Recruiting
UCSF Medical Center
San Francisco, California, 94134
Praveen Mummaneni, MD, +1 415-353-7500, praveen.mummaneni@ucsf.edu
Canada2 sites, 1 recruiting
- Terminated
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
- Recruiting
Vancouver General Hospital and the University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Nicolas Dea, MD, nicolas.dea@vch.ca
Italy2 sites, 2 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Alessandro Gasbarrini, MD, gasbarrini@me.com
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Alessandro Luzzati, MD, alessandroluzzati@gmail.com
Australia1 site
- Withdrawn
University of Queensland, School of Medicine
Brisbane, 4000 QLD
China1 site, 1 recruiting
- Recruiting
Peking University 3rd Hospital
Beijing, Beijing Municipality, 100191
Feng Wei, MD, mountweifeng@126.com
Germany1 site, 1 recruiting
- Recruiting
Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden
Dresden, 1307
Alexander Disch, PD, MD, alexander.disch@uniklinikum-dresden.de
Hungary1 site, 1 recruiting
- Recruiting
National Center for Spinal Disorders and Buda Health Center
Budapest, 1126
Aron P Lazary, MD, aron.lazary@bhc.hu
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals
Oxford, OX3 7HE
Jeremy Reynolds, jezreynolds@doctors.org.uk
About this study
Official title: Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
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.
Read the 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
- Conditions
- Spinal Column Tumor
- Keywords
- Registry, Spine, Surgery, Medical Oncology, Radiation Oncology, Neoplasms, Systemic Oncologic Therapy, Radiation Therapy, Tumor Markers
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.
Measured: Prior to surgical treatment
Survey on patient satisfaction
A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.
Measured: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Column TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Responsible party
- Sponsor
- Investigators
- Jeremy Reynolds, MD, Principal investigator, Clinical Lead for Spinal Surgery at Oxford University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790983
- Sponsor's protocol ID
- PTRON
- Acronym
- PTRON
- Status last verified
- Feb 2026
- First submitted
- 18 May 2016
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
- ClinicalTrials.gov ID
- NCT02790983
- Acronym / sponsor ID
- PTRON / PTRON
- Conditions
- Spinal Column Tumor
- Keywords
- Registry, Spine, Surgery, Medical Oncology, Radiation Oncology, Neoplasms, Systemic Oncologic Therapy, Radiation Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Study start
- Oct 2016
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with a primary tumor of the spine or patients with a history of a spine tumor
Key inclusion criteria (7 listed)
- 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.:
- OR
- Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
Key exclusion criteria (1 listed)
- Patient diagnosed with a metastatic tumor of the spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Reynolds, MD principal investigator
Clinical Lead for Spinal Surgery at Oxford University Hospitals
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Column Tumor, run by AO Innovation Translation Center at 19 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, Italy, Australia, China and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Thomas, PhD (+41 79 671 47 98, felix.thomas@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.