Metastatic Tumor Research and Outcomes Network (MTRON)

AO Innovation Translation Center

Status: Enrolling

Conditions: Metastatic Spine Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT02830451

MTRON

Details and patient eligibility

About

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).

Full 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

Enrollment: 960 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.