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Trial record 17 of 22 for:    aospine

Metastatic Tumor Research and Outcomes Network (MTRON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830451
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Tracking Information
First Submitted Date June 21, 2016
First Posted Date July 12, 2016
Last Update Posted Date May 9, 2019
Actual Study Start Date November 15, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2017)
  • Patient details [ Time Frame: collected at baseline ]
    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
  • Tumor details [ Time Frame: collected at baseline, first prospective treatment and follow-up ]
    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
  • Symptoms [ Time Frame: collected at baseline, first prospective treatment and follow-up ]
    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.
  • Treatment details - previous treatment of the index of the spine [ Time Frame: Collected at baseline ]
    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)
  • Imaging information [ Time Frame: collected at baseline, first prospective treatment, discharge and at follow-up. ]
    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
  • Patient reported outcomes - Euroqol EQ-5D-3L / - EQ-5D VAS [ Time Frame: collected at baseline, first prospective treatment, discharge and at follow-up. ]
    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.
  • Ambulation [ Time Frame: collected at baseline, discharge and at follow-up. ]
    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.
  • Nutritional status tool [ Time Frame: collected at baseline, first prospective treatment, discharge and at follow-up. ]
    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.
  • Morbidity data - Adverse events [ Time Frame: collected at first prospective treatment, discharge and at follow-up. ]
    • 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.
  • Local disease recurrence data [ Time Frame: collected at baseline and at follow-up. ]
    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.
  • Survival [ Time Frame: collected at first prospective treatment, discharge and at follow-up. ]
    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.
  • Treatment details - Current treatment of the index target of the spine [ Time Frame: collected at first prospective treatment and at follow-up. ]
    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.
  • Treatment details - Current treatment for the primary cancer [ Time Frame: collected at baseline, first prospective treatment and at follow-up. ]
    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.
  • Patient reported outcomes - Pain Numeric Rating Scale [ Time Frame: collected at baseline, first prospective treatment, discharge and at follow-up. ]
    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.
  • Patient reported outcomes - Spine Oncology Study Group Outcome Questionnaire (SOSGOQ) [ Time Frame: collected at baseline, first prospective treatment, discharge and at follow-up. ]
    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.
Original Primary Outcome Measures
 (submitted: July 8, 2016)
  • Metastatic tumor: date of initial diagnosis [ Time Frame: collected at baseline ]
  • Metastatic tumor: vertebral location [ Time Frame: collected at baseline ]
  • Metastatic tumor: site(s) of other metastases, if any [ Time Frame: Collected at baseline ]
  • Metastatic tumor: Activity of systemic metastases [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
  • Metastatic tumor: local control of metastatic tumor [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
  • Metastatic tumor: occurence of pathologic fractures [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
  • Metastatic tumor: radiographic evidence of new spine metastatic disease [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2017)
  • Symptoms: American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: collected at baseline, first prospective treatment, discharge and at follow-up. ]
    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
  • Symptoms: Eastern Cooperative Oncology Group (ECOG) classification [ Time Frame: collected at baseline, first prospective treatment, and at follow-up. ]
    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.
  • Symptoms: Epidural Compression Classification [ Time Frame: Collected at baseline ]
    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.
  • Spine Instability Neoplastic Score (SINS) [ Time Frame: collected at baseline and first prospective treatment, ]
    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.
Original Secondary Outcome Measures
 (submitted: July 8, 2016)
  • Symptoms: American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: Collected at baseline ]
    This scale has been modified from the Frankel classification and classifies the severity of injury as being neurologically complete or incomplete. It will be used to classify the overall neurologic status of patients.
  • Symptoms: American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    This scale has been modified from the Frankel classification and classifies the severity of injury as being neurologically complete or incomplete. It will be used to classify the overall neurologic status of patients.
  • Symptoms: Eastern Cooperative Oncology Group (ECOG) classification [ Time Frame: Collected at baseline ]
    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.
  • Symptoms: Eastern Cooperative Oncology Group (ECOG) classification [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    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.
  • Symptoms: Epidural Compression Classification [ Time Frame: Collected at baseline ]
    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.
  • Symptoms: Spine Instability Neoplastic Score (SINS) [ Time Frame: Collected at baseline ]
    The Spine Oncology Study Group 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 (0-6), indeterminate instability (7-12), and instability (13-18). Surgical consultation is recommended for patients with SINS scores ≥ 7.
  • Previous treatment of the metastatic tumor(s) of the spine: type of treatment [ Time Frame: Collected at baseline ]
    If the patient had previous treatment for the current metastatic spine tumor(s), type of the previous treatment will be collected for each tumor if multiple.
  • Previous treatment of the metastatic tumor(s) of the spine: date of treatment [ Time Frame: Collected at baseline ]
    If the patient had previous treatment for the current metastatic spine tumor(s), date of the previous treatment will be collected for each tumor if multiple.
  • Previous treatment of the metastatic tumor(s) of the spine: • Hospital/center where the treatment was administered [ Time Frame: Collected at baseline ]
    If the patient had previous treatment for the current metastatic spine tumor(s), Hospital/center where the treatment was administered will be collected for each tumor if multiple.
  • Current treatment of the metastatic tumor of the spine [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    At each follow-up visit, there will be an opportunity to indicate whether or not there has been a change in treatment (Surgical treatment, Radiation Therapy, Chemotherapy ).
  • Euroqol EQ-5D-3L [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status. EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
  • Pain Numeric Rating Scale [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.
  • Spine Oncology Study Group Outcome Questionnaire (SOSGOQ) [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    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 56 concepts representing all four domains of the International Classification of Function and Disability. 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.
  • Patient assessment [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    The patient assessment includes seven questions which are to be answered by the patient to collect the following information: smoking status, medication usage including, over the counter medication, muscle relaxants, narcotic pain medication, anti-depressants, and neuroleptics - agents to calm nerve pain. In addition, the patient will be asked how optimistic he/she is about the future improvement of his/her spine condition.
  • Perioperative morbidity data - early complications [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    Early 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 perioperative morbidity data.
  • Perioperative morbidity data - late complications [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    Early and late 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 perioperative morbidity data.
  • Local disease control data [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    At every follow-up 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 follow-up visits.
  • Overall survival data [ Time Frame: Every standard of care scheduled follow-up visit up to 5 years ]
    At every follow-up visit, each patient will be assessed in terms of their survival status. The assessment will be performed in accordance with local standard of care scheduled follow-up visits.
  • Site of the primary cancer [ Time Frame: collected at baseline ]
  • primary cancer - year of diagnosis [ Time Frame: collected at baseline ]
  • primary cancer - status of the tumor (removed or not) [ Time Frame: collected at baseline ]
  • primary cancer - signs of local control or tumor progression [ Time Frame: collected at baseline ]
  • primary cancer - tumor subtype [ Time Frame: collected at baseline ]
  • primary cancer - tumor markers [ Time Frame: collected at baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient diagnosed with a metastatic tumor of the spine.
Condition Metastatic Spine Tumor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 21, 2018)
960
Original Estimated Enrollment
 (submitted: July 8, 2016)
300
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Daniela Voegtli +41 81 414 25 10 daniela.voegtli@aofoundation.org
Contact: Benjamin Weiss +41 44 200 24 66 Benjamin.Weiss@aofoundation.org
Listed Location Countries Australia,   Canada,   Germany,   Hungary,   Italy,   Japan,   Netherlands,   Singapore,   Switzerland,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number NCT02830451
Other Study ID Numbers MTRON
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party AO Clinical Investigation and Documentation
Study Sponsor AO Clinical Investigation and Documentation
Collaborators AOSpine International
Investigators
Principal Investigator: Charles G. Fisher, MD Vancouver General Hospital and the University of British Columbia
PRS Account AO Clinical Investigation and Documentation
Verification Date December 2018