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JOURNAL ONKOLOGIE – STUDIE
MTRON

Metastatic Tumor Research and Outcomes Network

Rekrutierend

NCT-Nummer:
NCT02830451

Studienbeginn:
November 2017

Letztes Update:
20.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AO Innovation Translation Center

Collaborator:
AO Foundation, AO Spine

Studienleiter

Charles G. Fisher, MD
Principal Investigator
Vancouver General Hospital and the University of British Columbia

Kontakt

Studienlocations
(3 von 25)

Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Alexander Disch, MD
E-Mail: alexander.disch@uniklinikum-dresden.de» Ansprechpartner anzeigen
University of California The UCSF Spine Center Department of Neurological Surgery
94143 San Francisco
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dean Chou, MD
E-Mail: dean.chou@ucsf.edu» Ansprechpartner anzeigen
University of Rochester School of Medicine and Dentistry Department of Orthopaedic Surgery and Neurosurgery
14642 Rochester
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Addisu Mesfin, MD
E-Mail: amesfin@gmail.com» Ansprechpartner anzeigen
Westchester Medical Center Department of Neurosurgery
10595 Valhalla
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Meic Schmidt, MD
Phone: 914-493-5098
E-Mail: Meic.Schmidt@wmchealth.org

Rachel Lehrer, MD
E-Mail: Rachel.Lehrer@wmchealth.org» Ansprechpartner anzeigen
The Warren Alpert Medical School of Brown university Department of Neurosurgery
02903 Providence
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ziya L Gokaslan, MD
E-Mail: ziya_gokaslan@brown.edu» Ansprechpartner anzeigen
The University of Texas MD Anderson Cancer Center Department of Neurosurgery
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Laurence D Rhines, MD
E-Mail: lrhines@mdanderson.org» Ansprechpartner anzeigen
Winnipeg Spine Program University of Manitoba Department of Surgery
R3A 1R9 Winnipeg
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Michael Johnson, MD
E-Mail: MGJohnson@exchange.hsc.mb.ca» Ansprechpartner anzeigen
Toronto Western Hospital Department of Neurosurgery Division of Surgery
4W449 Toronto
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Michael G Fehlings, MD
Phone: +1 416 603 5627
E-Mail: michael.fehlings@uhn.on.ca» Ansprechpartner anzeigen
University of Toronto Odette Cancer Centre - T2 158 Sunnybrook Health Sciences Ccenter
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Arjun Saghal, MD
E-Mail: arjunsahgal@yahoo.com» Ansprechpartner anzeigen
Instituto Ortopedico Rizzoli Department of Oncologic and Degenerative Spine Surgery
40136 Bologna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Alessandro Gasbarrini
E-Mail: gasbarrini@me.com» Ansprechpartner anzeigen
IRCCS Istituto Ortopedico Galeazzi Centro die Chirurgia Ortopedica Oncologica e Ricostr
20161 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Alessandro Luzzati, MD
E-Mail: alessandroluzzati@gmail.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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

2. 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

3. 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.

4. 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)

5. 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

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

Secondary outcome:

1. 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

2. 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.

3. 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.

4. 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.

Quelle: ClinicalTrials.gov


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