Language: BG BG
← Back to results
Recruiting NCT02790983

Primary Tumor Research and Outcomes Network

Conditions: Spinal Column Tumor

Sponsor: AO Innovation Translation Center

trial.available_in: БГ
Overview
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.
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
Who can participate
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.
Locations 9
Australia (1)
University of Queensland, School of Medicine
Brisbane
WITHDRAWN
Canada (1)
Vancouver General Hospital and the University of British Columbia
Vancouver , British Columbia
Nicolas Dea, MD
China (1)
Peking University 3rd Hospital
Beijing , Beijing Municipality
Germany (1)
Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden
Dresden
Hungary (1)
National Center for Spinal Disorders and Buda Health Center
Budapest
Aron P Lazary, MD
Italy (1)
Istituto Ortopedico Rizzoli
Bologna
Alessandro Gasbarrini, MD
Japan (1)
Kanazawa Medical University Hospital
Kanazawa
TERMINATED
United Kingdom (1)
Oxford University Hospitals
Oxford
United States (1)
University of California
Los Angeles , California
TERMINATED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.10.2016
Completion date
01.12.2028
Registry ID
NCT02790983
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.