UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047302 |
|---|---|
| Receipt number | R000053852 |
| Scientific Title | Establishment of chemobrain estimation by measuring exosome. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/11/12 10:33:03 |
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Basic information
Public title
Establishment of chemobrain estimation by measuring exosome.
Acronym
Finding exosome biomaker of chemobrain.
Scientific Title
Establishment of chemobrain estimation by measuring exosome.
Scientific Title:Acronym
Clinical trial.
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Chemobrain is a condition in which higher brain functions are impaired by anticancer drug treatment. Despite the importance of chemobrain in patients' quality of life, there are no established clinical criteria for its diagnosis. The biggest problem is that there is no objective biomarker to serve as an indicator. The purpose of this study is to discover exosomes that can serve as this biomarker, to diagnose chemobrain at an early stage, and to monitor the disease status, thereby contributing to the health of patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chemobrain status will be evaluated by cognitive function tests and analyzed for correlation with blood exosome levels and changes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
blood test, 10 times.
brain function test, 4 times.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
First chemotherapy after diagnosis of cancer,
Key exclusion criteria
Those who are suffering from serious recognition disorder or psychiatric disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
7008505
Address
2-6-1, Nakasange, Kita-ku, Okayama city, Okayama
TEL
0862552111
t.muratactac@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
7008505
Address
2-6-1, Nakasange, Kita-ku, Okayama city, Okayama
TEL
0862552111
Homepage URL
https://g.kawasaki-m.ac.jp/dept/sanfujin/ekigaku
t.muratactac@gmail.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kwasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NanoSomiX co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
577, Matsushima, Kurashiki city, Okayama
Tel
0862252111
kmsrec@med.kawasaki-m.ac.jp
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
川崎医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
