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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011842
Receipt No. R000013842
Scientific Title The functional prognosis of neurological disorder by bone metastasis with using MRI
Date of disclosure of the study information 2013/10/01
Last modified on 2016/03/23

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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
Interventions/Control_6
Interventions/Control_7
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
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
Registered date File name


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