Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Dean Chou

Description

Summary

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).

Official Title

Metastatic Tumor Research and Outcome Network A Multicenter Prospective Registry for the Management and Outcome of Metastatic Spine Tumors

Details

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

Keywords

Metastatic Spine Tumor Registry Spine Surgery Medical Oncology Radiation Oncology Neoplasms Metastasis Chemotherapy Radiation Therapy Tumor Markers Neoplasm Metastasis

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

• Patient diagnosed with a primary tumor of the spine.

Locations

  • University of California The UCSF Spine Center Department of Neurological Surgery not yet accepting patients
    San Francisco California 94143 United States
  • Vancouver General Hospital and the University of British Columbia accepting new patients
    Vancouver British Columbia V5Z 1M9 Canada

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AO Clinical Investigation and Documentation
ID
NCT02830451
Study Type
Observational [Patient Registry]
Last Updated