Metastatic Tumor Research and Outcomes Network
Purpose
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
Condition
- Metastatic Spine Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient 18 or older. - Patient diagnosed with a metastatic tumor of the spine - 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 - Signed and dated EC/IRB approved written informed consent (if consent is required by the EC/ IRB at the registry site)
Exclusion Criteria
• Patient diagnosed with a primary tumor of the spine.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- AO Innovation Translation Center
Detailed Description
To prospectively determine the prognostic variables (clinical, diagnostic, and therapeutic) within patients diagnosed with metastatic spine tumor(s) that are associated with: - patient reported outcomes (HRQOL) - morbidity data - local tumor control - survival Outcome measures: Variables which will be collected in the registry that are applicable to patients with metastatic spine tumor include: - • Patient details - Details of previous treatment - Diagnosis - Symptoms - Treatment details for the index target - Imaging information The following outcome measures will be collected: - Patient reported outcomes: - Euroqol EQ-5D-3L - Euroqol EQ-5D VAS - Quality of Life - Neck Pain Numeric Rating Scale (NRS) - Arm Pain NRS - Back Pain NRS - Leg Pain NRS - SOSGOQ - Patient assessment - Ambulation - Pain medication - Nutritional Status Tool (PG-SGA©) - Morbidity data - Local disease recurrence data - Overall survival data