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Primary Tumor Research and Outcomes Network

NCT ID: NCT02790983

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Spinal Column Tumor

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Foundation, AO Spine

OTHER

Sponsor Role collaborator

AO Innovation Translation Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Lead for Spinal Surgery at Oxford University Hospitals

Locations

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University of California

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

UCSF Medical Center

San Francisco, California, United States

Site Status RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

University of Queensland, School of Medicine

Brisbane, , Australia

Site Status SUSPENDED

Vancouver General Hospital and the University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Peking University 3rd Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden

Dresden, , Germany

Site Status RECRUITING

National Center for Spinal Disorders and Buda Health Center

Budapest, , Hungary

Site Status RECRUITING

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Kanazawa Medical University Hospital

Kanazawa, , Japan

Site Status TERMINATED

Oxford University Hospitals

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Canada China Germany Hungary Italy Japan United Kingdom

Central Contacts

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Benjamin Bretzinger

Role: CONTACT

Phone: +41 79 814 01 48

Email: [email protected]

Felix Thomas

Role: CONTACT

Phone: +41 79 671 47 98

Email: [email protected]

Facility Contacts

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Praveen Mummaneni, MD

Role: primary

Chetan Bettegowda, MD

Role: primary

John H Shin, MD

Role: primary

Michelle Clarke, MD

Role: primary

Mark Bilsky

Role: primary

Ori Barilai, MD

Role: primary

Ziya L. Gokaslan, MD

Role: primary

Laurence D. Rhines, MD

Role: primary

Nicolas Dea, MD

Role: primary

Yoga Raja Rampersaud, MD, PhD

Role: primary

Feng Wei, MD

Role: primary

Alexander Disch, PD, MD

Role: primary

Aron P Lazary, MD

Role: primary

Alessandro Gasbarrini, MD

Role: primary

Alessandro Luzzati, MD

Role: primary

Jeremy Reynolds

Role: primary

Other Identifiers

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PTRON

Identifier Type: -

Identifier Source: org_study_id