UMIN-CTR Clinical Trial

Basic information
Public title	The functional prognosis of neurological disorder by bone metastasis with using MRI
Acronym	The functional prognosis of neurological disorder by bone metastasis with using MRI
Scientific Title	The functional prognosis of neurological disorder by bone metastasis with using MRI
Scientific Title:Acronym	The functional prognosis of neurological disorder by bone metastasis with using MRI
Region	Japan

Condition
Condition	bone metastasis
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Orthopedics Urology Radiology Neurosurgery Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Malignant Spinal cord compression causes paralysis and/or bladder and rectal disturbance. Some recover from neurological disorder by being treated by radiation with/without rehabilitation, while others do not. Our hypothesis is that we can determine whether or not the neurological disorder will recover with radiation (+ rehabilitation) by evaluating the attainment of the damage, if it reaches the gray matter of the spinal cord or remain within the white matter. Using MRI, we reveal how far the spinal cord have been damaged, and compare the functional prognosis of those with damage come up to the gray matter and those with damage remained only in the white matter.
Basic objectives2	Others
Basic objectives -Others	prognosis prediction
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The percentage of the patient who recovered MMT (who measured more than 4) The patient will measure their MMTs after being treated for a year. We will examine if there is a significant difference between the two groups by using the Chi-square test.
Key secondary outcomes	The percentage of the patients who recoverd neuritis (bladder and rectum disturbance) The patient will self-assess the recovery of the neuritis after being treated for a year. We will examine if the is a significant difference between the two groups by using the Chi-square test.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The target will de patients who have suffered from neuritis such as paralysis (lower than MMT 3) or/and bladder and rectum disturbance due to metastatic tumors of the spinal cord.
Key exclusion criteria	1. The patient wishes to resign from the project. 2. The patient has been decided not to match the criteria after being registered to the project. 3. The symptoms of the neuritis has worsened and it is hard for the patient to continue participating. 4. Some harmful matter happened to the patient and it was hard for the patient to participate. 5. The project has been called off. 6. The doctor decided the patient should not participate in any case.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Sasai
Organization	Juntendo University Hospital
Division name	radiation oncology
Zip code
Address	Tokyo bunkyo ward hongo 3-1-3
TEL	03-3813-3111
Email	ksasai@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Taito Asahina
Organization	Juntendo University Hospital
Division name	radiation oncology
Zip code
Address	Tokyo bunkyo ward hongo 3-1-
TEL	03-3813-3111
Homepage URL
Email	tasahina@juntendo.ac.jp

Sponsor
Institute	Juntendo University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
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Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学医学部付属順天堂医院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry	2019 Year 10 Month 01 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 01 Month 31 Day

Other
Other related information	Prospective study

Management information
Registered date	2013 Year 09 Month 23 Day
Last modified on	2016 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013842

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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