Clinical trial NCT02830451: Metastatic Tumor Research and Outcomes Network
Official title: Metastatic Tumor Research and Outcome Network A Multicenter Prospective Registry for the Management and Outcome of Metastatic Spine Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Spine Tumor
Keywords: Registry
Spine
Surgery
Medical Oncology
Radiation Oncology
Neoplasms
Metastasis
Chemotherapy
Radiation Therapy
Tumor Markers
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AO Foundation, AO Spine
First posted: 2016-07-12
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed with a metastatic tumor of the spine.

Brief 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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: Patient details
timeFrame: collected at baseline
measure: Tumor details
timeFrame: collected at baseline, first prospective treatment and follow-up
measure: Symptoms
timeFrame: collected at baseline, first prospective treatment and follow-up
measure: Treatment details - previous treatment of the index of the spine
timeFrame: Collected at baseline
measure: Imaging information
timeFrame: collected at baseline, first prospective treatment, discharge and at follow-up.
measure: Patient reported outcomes - Euroqol EQ-5D-3L / - EQ-5D VAS
timeFrame: collected at baseline, first prospective treatment, discharge and at follow-up.
measure: Ambulation
timeFrame: collected at baseline, discharge and at follow-up.
measure: Nutritional status tool
timeFrame: collected at baseline, first prospective treatment, discharge and at follow-up.
measure: Morbidity data - Adverse events
timeFrame: collected at first prospective treatment, discharge and at follow-up.
measure: Local disease recurrence data
timeFrame: collected at baseline and at follow-up.
measure: Survival
timeFrame: collected at first prospective treatment, discharge and at follow-up.
measure: Treatment details - Current treatment of the index target of the spine
timeFrame: collected at first prospective treatment and at follow-up.
measure: Treatment details - Current treatment for the primary cancer
timeFrame: collected at baseline, first prospective treatment and at follow-up.
measure: Patient reported outcomes - Pain Numeric Rating Scale
timeFrame: collected at baseline, first prospective treatment, discharge and at follow-up.
measure: Patient reported outcomes - Spine Oncology Study Group Outcome Questionnaire (SOSGOQ)
timeFrame: collected at baseline, first prospective treatment, discharge and at follow-up.
Secondary outcomes:
measure: Symptoms: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: collected at baseline, first prospective treatment, discharge and at follow-up.
measure: Symptoms: Eastern Cooperative Oncology Group (ECOG) classification
timeFrame: collected at baseline, first prospective treatment, and at follow-up.
measure: Symptoms: Epidural Compression Classification
timeFrame: Collected at baseline
measure: Spine Instability Neoplastic Score (SINS)
timeFrame: collected at baseline and first prospective treatment,
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California The UCSF Spine Center Department of Neurological Surgery
state: California
city: Chicago
country: United States
facility: Rush University Medical Center University Neurosurgery
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University Department of Neurosurgery / Spine Division
state: Maryland
city: Boston
country: United States
facility: Harvard Medical School Department of Neurosurgery
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Department of Neurosurgery
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester School of Medicine and Dentistry Department of Orthopaedic Surgery and Neurosurgery
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center Department of Neurosurgery
state: New York
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center Department of Neurosurgery
state: Pennsylvania
city: Providence
country: United States
facility: The Warren Alpert Medical School of Brown university Department of Neurosurgery
state: Rhode Island
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center Department of Neurosurgery
state: Texas
city: Clayton
country: Australia
facility: Monash University Melbourne
state: Victoria
city: Vancouver
country: Canada
facility: Vancouver General Hospital and the University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Spine Program University of Manitoba Department of Surgery
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Western Hospital Department of Neurosurgery Division of Surgery
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Odette Cancer Centre - T2 158 Sunnybrook Health Sciences Ccenter
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
state: Sachsen
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders and Buda Health Center
city: Bologna
country: Italy
facility: Instituto Ortopedico Rizzoli Department of Oncologic and Degenerative Spine Surgery
state: Emilia-Romagna
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi Centro die Chirurgia Ortopedica Oncologica e Ricostr
state: Lombardei
city: Uchinoda
country: Japan
facility: Kanazawa Medical University Hospital Department of Orthopaedic Surgery
state: Ishikawa
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Singapore
country: Singapore
facility: National University of Singapore Department of Orthopaedic Surgery
city: Basel
country: Switzerland
facility: Universitätsspital Basel Wirbelsäulenzentrum
Study officials:
affiliation: Vancouver General Hospital and the University of British Columbia
name: Charles G. Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References: