Metastatic Tumor Research and Outcomes Network

NCT02830451 | Active Not Recruiting

• 1 other identifier: MTRON
• Study Type: observational
• Target: 960
• Locations: 10 countries
• Sites: 24

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).

Conditions

Metastatic Spine Tumor

Keywords

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

Outcome Measures

Primary Outcomes (15)

• Patient details

  The following patient data will be collected: * gender, year of birth, height, weight, race * work status, education level, marital status * smoking, alcohol and recreational drug use * medication use * nutrition and vitamin intake * presence of osteoporosis * comorbidities according to the Charlson Comorbidity Index - CCI

  collected at baseline

• Tumor details

  Primary cancer * Site of the primary cancer * Year of diagnosis * Status of the tumor (removed completely, partially, or not removed) * Signs of local control or tumor progression * Tumor subtype * Tumor markers Spine metastases * Date of initial diagnosis of spine metastases * Identification of index target * Vertebral location (i.e., C1, T3-T5, etc.) * Details of spine metastases and other metastases, if any * Activity of systemic metastases * Local control of metastatic tumor * Presence of pathologic fracture * Radiographic evidence of new spine metastatic disease

  collected at baseline, first prospective treatment and follow-up

• Symptoms

  For patients with metastatic spine tumor, it is important to understand the occurrence, location, and type of pain patients have at baseline and at follow-up visits. Pain symptoms assessed by the physician will therefore be collected in addition to the pain specific PROs. Bowel and bladder function will be assessed by the physician.

  collected at baseline, first prospective treatment and follow-up

• Treatment details - previous treatment of the index of the spine

  If the patient had previous treatment (surgery, radiation or systemic oncologic therapy) for the index target, the following information about the previous treatment will be collected at baseline: * Type(s) of treatment * Date(s) of treatment * Treated vertebrae level(s) * Procedure details * Hospital/center where the treatment was administered * ASIA impairment scale (applies only to previous surgical patients)

  Collected at baseline

• Imaging information

  Skeletal muscle and adipose tissue measurements will be made from CT scans. One transverse CT image of the inferior surface of L3 will be assessed by an independent assessor to calculate the visceral fat area to subcutaneous fat ratio (VFA/SFA ratio). This measurement will only be collected if the CT scan is according to standard of care and the method is described in a separate imaging manual. Additional CT scans will not be performed for this Registry. Imaging is critical to select the biopsy technique and for disease diagnosis. Follow-up imaging also plays an important role in monitoring disease status. Imaging data will be collected to serve as a data repository, so that images may be more easily retrieved later if necessary. Imaging data * Image type (e.g. MRI, CT, PET, etc.) * Date taken * Name of institution storing image

  collected at baseline, first prospective treatment, discharge and at follow-up.

• Patient reported outcomes - Euroqol EQ-5D-3L / - EQ-5D VAS

  The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  collected at baseline, first prospective treatment, discharge and at follow-up.

• Ambulation

  Details about the ability of the patient to walk, cause of ambulation loss, use of an assistive device, and timing will be collected. 10 meter walk test (10 MWT) If the patient is able to ambulate without physical assistance (i.e. without help of a person), ambulation will be assessed by the 10MWT (walking aids are allowed). The 10MWT evaluates the time required to walk 10 meters. Patients should walk 10 meters with 2 meters for acceleration and deceleration. The patient will be timed from when the patient's toes of the leading foot cross the 2 meter line to when the patient's toes of the leading foot cross the 8 meter line. The test should be performed three times and the results will be averaged. The patient should be instructed to perform the test at a comfortable walking pace.

  collected at baseline, discharge and at follow-up.

• Nutritional status tool

  The Scored Patient-Generated Subjective Global Assessment (PG-SGA©) sets the standard of and is the preeminent interdisciplinary patient assessment (weight, intake, symptoms, functional status, disease state, metabolic stress and nutritional physical examination) in oncology and other chronic catabolic conditions. The Scored PG-SGA© includes the four patient-generated historical components ('Weight History', 'Food Intake', 'Symptoms' and 'Activities and Function'), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage recommendations. Subsequently, the Scored PG-SGA© allows for triaging of specific nutrition interventions, as well as facilitating quantitative outcomes data collection. This assessment is available in a variety of languages and as a metric as well as a non-metric version.

  collected at baseline, first prospective treatment, discharge and at follow-up.

• Morbidity data - Adverse events

  * related to surgery Intra- and postoperative complication data will be recorded for all surgically treated patients during the standard of care scheduled follow-up visits. Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up. The Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool will be used to record the morbidity data. * related to radiation and/or systemic oncologic therapy For patients treated with RT and/or systemic oncologic therapy, complications and severity grade related to the treatment will be recorded during the standard of care scheduled follow-up visits according to a predefined list: The predefined list and severity grading system are according to the National Cancer Institute Guidelines.

  collected at first prospective treatment, discharge and at follow-up.

• Local disease recurrence data

  At every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease control. Presence or absence of local control and distant metastases should be confirmed through imaging. The timing of the assessment will be performed in accordance with local standard of care scheduled FU visits.

  collected at baseline and at follow-up.

• Survival

  FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive.

  collected at first prospective treatment, discharge and at follow-up.

• Treatment details - Current treatment of the index target of the spine

  Since there is a spectrum of different treatment options and combinations for patients with a metastatic spine tumor, detailed information about the three main treatment options (surgery, radiation, and systemic oncologic therapy) for the index target will be collected. The treatment intent, including administration (primary, neo-adjuvant, and adjuvant) will also be collected.

  collected at first prospective treatment and at follow-up.

• Treatment details - Current treatment for the primary cancer

  Information on the status of the primary cancer as well as on ongoing treatment of the primary cancer will be collected at baseline and at follow-up.

  collected at baseline, first prospective treatment and at follow-up.

• Patient reported outcomes - Pain Numeric Rating Scale

  The Pain NRS is an 11-point scale where the end points are the extremes of no pain (0 points), or worst imaginable pain (10 points). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.

  collected at baseline, first prospective treatment, discharge and at follow-up.

• Patient reported outcomes - Spine Oncology Study Group Outcome Questionnaire (SOSGOQ)

  This is a new HRQOL outcome tool which was developed specifically for metastatic spine tumor. It is currently available in English and Hungarian. It contains 20 items representing all four domains of the International Classification of Function and Disability. Additionally there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the SF-36 for patients with spine tumors.

  collected at baseline, first prospective treatment, discharge and at follow-up.

Secondary Outcomes (4)

• Symptoms: American Spinal Injury Association (ASIA) Impairment Scale

  collected at baseline, first prospective treatment, discharge and at follow-up.

• Symptoms: Eastern Cooperative Oncology Group (ECOG) classification

  collected at baseline, first prospective treatment, and at follow-up.

• Symptoms: Epidural Compression Classification

  Collected at baseline

• Spine Instability Neoplastic Score (SINS)

  collected at baseline and first prospective treatment,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with a metastatic tumor of the spine.

You may qualify if:

• 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 may not qualify if:

• Patient diagnosed with a primary tumor of the spine.

Sponsors & Collaborators

• AO Innovation Translation Center: lead
• AO Foundation, AO Spine: collaborator

Study Sites (24)

University of California The UCSF Spine Center Department of Neurological Surgery

San Francisco, California, 94143, United States

Location

Rush University Medical Center University Neurosurgery

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University Department of Neurosurgery / Spine Division

Baltimore, Maryland, 21205, United States

Location

Harvard Medical School Department of Neurosurgery

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic Department of Neurosurgery

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester School of Medicine and Dentistry Department of Orthopaedic Surgery and Neurosurgery

Rochester, New York, 14642, United States

Location

Penn Presbyterian Medical Center Department of Neurosurgery

Philadelphia, Pennsylvania, 19104, United States

Location

The Warren Alpert Medical School of Brown university Department of Neurosurgery

Providence, Rhode Island, 02903, United States

Location

The University of Texas MD Anderson Cancer Center Department of Neurosurgery

Houston, Texas, 77030, United States

Location

Monash University Melbourne

Clayton, Victoria, 3168, Australia

Location

Vancouver General Hospital and the University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Winnipeg Spine Program University of Manitoba Department of Surgery

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Toronto Western Hospital Department of Neurosurgery Division of Surgery

Toronto, Ontario, 4W449, Canada

Location

University of Toronto Odette Cancer Centre - T2 158 Sunnybrook Health Sciences Ccenter

Toronto, Ontario, M4N 3M5, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

Location

National Center for Spinal Disorders and Buda Health Center

Budapest, 1126, Hungary

Location

Instituto Ortopedico Rizzoli Department of Oncologic and Degenerative Spine Surgery

Bologna, Emilia-Romagna, 40136, Italy

Location

IRCCS Istituto Ortopedico Galeazzi Centro die Chirurgia Ortopedica Oncologica e Ricostr

Milan, Lombardy, 20161, Italy

Location

Kanazawa Medical University Hospital Department of Orthopaedic Surgery

Uchinoda, Ishikawa-ken, 920-0293, Japan

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3508, Netherlands

Location

National University of Singapore Department of Orthopaedic Surgery

Singapore, 119288, Singapore

Location

Universitätsspital Basel Wirbelsäulenzentrum

Basel, Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles G. Fisher, MD

  Vancouver General Hospital and the University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 12, 2016
• Study Start: November 15, 2017
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); NL (1); HU (1); IT (2); US (10); DE (1); CA (5); CH (1); AU (1); SG (1)