UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011842
Receipt number 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 13:33:40

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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 or person

Institute

Juntendo University Hospital

Institute

Department

Personal name



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

Value
https://center6.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