Metastatic Tumor Research and Outcomes Network (MTRON)

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    960
  • sponsor
    AO Innovation Translation Center
Updated on 30 January 2022

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).

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

Details
Condition Metastatic Spine Tumor
Clinical Study IdentifierNCT02830451
SponsorAO Innovation Translation Center
Last Modified on30 January 2022

Eligibility

Yes No Not Sure

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
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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