Primary Tumor Research and Outcomes Network

Официальное название

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

Обзор

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.

Подробное описание

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

Первичные конечные точки

• Overall survival data [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (6)

• Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Prior to surgical treatment]
• Survey on patient satisfaction [Срок оценки: After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 9 центров

• University of California — Los Angeles
• UCSF Medical Center — San Francisco
• Johns Hopkins University School of Medicine — Baltimore
• Massachusetts General Hospital — Boston
• Mayo Clinic — Rochester
• Memorial Sloan-Kettering Cancer Center — New York
• Memorial Sloan Kettering Cancer Center — New York
• Rhode Island Hospital — Providence
• … и ещё 1 центр

Канада · 2 центра

• Vancouver General Hospital and the University of British Columbia — Vancouver
• Toronto Western Hospital — Toronto

Италия · 2 центра

• Istituto Ortopedico Rizzoli — Bologna
• IRCCS Istituto Ortopedico Galeazzi — Milan

Австралия · 1 центр

• University of Queensland, School of Medicine — Brisbane

Китай · 1 центр

• Peking University 3rd Hospital — Пекин

Германия · 1 центр

• Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden — Dresden

Венгрия · 1 центр

• National Center for Spinal Disorders and Buda Health Center — Budapest

Япония · 1 центр

• Kanazawa Medical University Hospital — Kanazawa

Великобритания · 1 центр

• Oxford University Hospitals — Oxford

Идентификаторы

NCT: NCT02790983 · PTRON

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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