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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.