Primary Tumor Research and Outcomes Network
a study on Spinal Column Tumor Neoplasms
Summary
- Location
- at UCLA UCSF
- Dates
- study startedcompletion around
Description
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.
Official Title
Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine
Details
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
Keywords
Spinal Column Tumor, Registry, Spine, Surgery, Medical Oncology, Radiation Oncology, Neoplasms, Systemic Oncologic Therapy, Radiation Therapy, Tumor Markers
Eligibility
You can join if…
- 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
You CAN'T join if...
- Patient diagnosed with a metastatic tumor of the spine.
Locations
- University of California
in progress, not accepting new patients
Los Angeles California 90095 United States - UCSF Medical Center
accepting new patients
San Francisco California 94134 United States - Vancouver General Hospital and the University of British Columbia
accepting new patients
Vancouver British Columbia V5Z 1M9 Canada
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- AO Innovation Translation Center
- ID
- NCT02790983
- Study Type
- Observational [Patient Registry]
- Participants
- Expecting 1350 study participants
- Last Updated