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

Harvard Medical School Department of Neurosurgery
Boston, Massachusetts 02114
Contact:
John Shin
617-803-7021
shin.John@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
AO Innovation Translation Center

Study Contact

Benjamin Bretzinger
+41 79 814 01 48
benjamin.bretzinger@aofoundation.org

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