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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02830451




Registration number
NCT02830451
Ethics application status
Date submitted
21/06/2016
Date registered
12/07/2016

Titles & IDs
Public title
Metastatic Tumor Research and Outcomes Network
Scientific title
Metastatic Tumor Research and Outcome Network A Multicenter Prospective Registry for the Management and Outcome of Metastatic Spine Tumors
Secondary ID [1] 0 0
MTRON
Universal Trial Number (UTN)
Trial acronym
MTRON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Spine Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient details
Assessment method [1] 0 0
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
Timepoint [1] 0 0
collected at baseline
Primary outcome [2] 0 0
Tumor details
Assessment method [2] 0 0
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
Timepoint [2] 0 0
collected at baseline, first prospective treatment and follow-up
Primary outcome [3] 0 0
Symptoms
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
collected at baseline, first prospective treatment and follow-up
Primary outcome [4] 0 0
Treatment details - previous treatment of the index of the spine
Assessment method [4] 0 0
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)
Timepoint [4] 0 0
Collected at baseline
Primary outcome [5] 0 0
Imaging information
Assessment method [5] 0 0
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
Timepoint [5] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [6] 0 0
Patient reported outcomes - Euroqol EQ-5D-3L / - EQ-5D VAS
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [7] 0 0
Ambulation
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
collected at baseline, discharge and at follow-up.
Primary outcome [8] 0 0
Nutritional status tool
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [9] 0 0
Morbidity data - Adverse events
Assessment method [9] 0 0
* 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.
Timepoint [9] 0 0
collected at first prospective treatment, discharge and at follow-up.
Primary outcome [10] 0 0
Local disease recurrence data
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
collected at baseline and at follow-up.
Primary outcome [11] 0 0
Survival
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
collected at first prospective treatment, discharge and at follow-up.
Primary outcome [12] 0 0
Treatment details - Current treatment of the index target of the spine
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
collected at first prospective treatment and at follow-up.
Primary outcome [13] 0 0
Treatment details - Current treatment for the primary cancer
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
collected at baseline, first prospective treatment and at follow-up.
Primary outcome [14] 0 0
Patient reported outcomes - Pain Numeric Rating Scale
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Primary outcome [15] 0 0
Patient reported outcomes - Spine Oncology Study Group Outcome Questionnaire (SOSGOQ)
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Secondary outcome [1] 0 0
Symptoms: American Spinal Injury Association (ASIA) Impairment Scale
Assessment method [1] 0 0
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit. The modified ISNCSCI used in this study will assess the Motor Score and the American Spinal Injury Association (ASIA) Impairment Scale
Timepoint [1] 0 0
collected at baseline, first prospective treatment, discharge and at follow-up.
Secondary outcome [2] 0 0
Symptoms: Eastern Cooperative Oncology Group (ECOG) classification
Assessment method [2] 0 0
The ECOG developed a scale from 0 to 5 to assess the patient's disease progression and how the disease affects the patient's daily living abilities (9). The lower the score the better the status of the patient, being 0 fully active and 5 dead.
Timepoint [2] 0 0
collected at baseline, first prospective treatment, and at follow-up.
Secondary outcome [3] 0 0
Symptoms: Epidural Compression Classification
Assessment method [3] 0 0
The Spine Oncology Study Group developed and validated a 6-point grading system to describe the degree of epidural spinal cord compression based on axial T2-weighted MR images at the site of most severe compression. This assessment can be used to help guide treatment and can serve as a classification scheme.
Timepoint [3] 0 0
Collected at baseline
Secondary outcome [4] 0 0
Spine Instability Neoplastic Score (SINS)
Assessment method [4] 0 0
The SOSG developed and validated a classification system to assist clinicians in defining tumor-related instability. It is assessed by adding together six individual component scores: spine location, pain, lesion bone quality, radiographic alignment, vertebral body collapse, and posterolateral involvement of the spinal elements. SINS has demonstrated clinically acceptable reliability among surgeons, radiation oncologists, and radiologists. The total SINS score can range from a score of 0 to 18. The total score has been divided into three categories of stability: stability (score of 0-6), indeterminate instability (score of 7-12), and instability (score of 13-18). Surgical consultation is recommended for patients with SINS scores = 7. SINS will be assessed at baseline and/or prior to first prospective treatment. The most severe lesion within the index target should be assessed.
Timepoint [4] 0 0
collected at baseline and first prospective treatment,

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient diagnosed with a primary tumor of the spine.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
960
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University Melbourne - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Manitoba
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Germany
State/province [14] 0 0
Sachsen
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Italy
State/province [16] 0 0
Emilia-Romagna
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardei
Country [18] 0 0
Japan
State/province [18] 0 0
Ishikawa
Country [19] 0 0
Netherlands
State/province [19] 0 0
Utrecht
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Switzerland
State/province [21] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Other
Name
AO Innovation Translation Center
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
AO Foundation, AO Spine
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Charles G. Fisher, MD
Address 0 0
Vancouver General Hospital and the University of British Columbia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Benjamin Bretzinger
Address 0 0
Country 0 0
Phone 0 0
+41 79 814 01 48
Email 0 0
benjamin.bretzinger@aofoundation.org
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02830451