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Spots Global Cancer Trial Database for Primary Tumor Research and Outcomes Network

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Trial Identification

Brief Title: Primary Tumor Research and Outcomes Network

Official Title: Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine

Study ID: NCT02790983

Interventions

Study Description

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.

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

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California, Los Angeles, California, United States

UCSF Medical Center, San Francisco, California, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Mayo Clinic, Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Rhode Island Hospital, Providence, Rhode Island, United States

The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

University of Queensland, School of Medicine, Brisbane, , Australia

Vancouver General Hospital and the University of British Columbia, Vancouver, British Columbia, Canada

Toronto Western Hospital, Toronto, Ontario, Canada

Peking University 3rd Hospital, Beijing, Beijing, China

Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden, Dresden, , Germany

National Center for Spinal Disorders and Buda Health Center, Budapest, , Hungary

Istituto Ortopedico Rizzoli, Bologna, , Italy

IRCCS Istituto Ortopedico Galeazzi, Milano, , Italy

Kanazawa Medical University Hospital, Kanazawa, , Japan

Oxford University Hospitals, Oxford, , United Kingdom

Contact Details

Name: Jeremy Reynolds, MD

Affiliation: Clinical Lead for Spinal Surgery at Oxford University Hospitals

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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