UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052697 |
|---|---|
| Receipt number | R000060135 |
| Scientific Title | Biomarkers of Neurological Diseases and iPS Cell-Based Disease Research |
| Date of disclosure of the study information | 2023/11/05 |
| Last modified on | 2023/11/05 10:17:16 |
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Basic information
Public title
Biomarkers of Neurological Diseases and iPS Cell-Based Disease Research
Acronym
Biomarkers of Neurological Diseases and iPS Cell Research
Scientific Title
Biomarkers of Neurological Diseases and iPS Cell-Based Disease Research
Scientific Title:Acronym
Biomarkers of Neurological Diseases and iPS Cell Research
Region
| Japan |
Condition
Condition
Neurological Diseases
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this study, we will analyze body fluid biomarkers and iPS cells of patients with neurodegenerative diseases treated at Keio University Hospital. The objective is to integrate and analyze clinical data, body fluid biomarkers, and iPS cell results to establish diagnostic methods for body fluid biomarkers of neurodegenerative diseases and to develop drugs using iPS cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This research is expected to establish diagnostic methods for fluid biomarkers of neurodegenerative diseases and to develop drugs using iPS cells.
Key secondary outcomes
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
Patients with neurodegenerative diseases who received treatment at Keio University Hospital between October 1, 2022 and March 30, 2032 will be eligible for this study. The subjects must agree to participate in this study. Subjects must be at least 18 years of age. If it is difficult to obtain consent from the subject himself/herself at the time of obtaining consent due to a consciousness disorder, dementia, mental retardation, etc., consent will be obtained from a surrogate. The physician in charge selects a person who is considered to be able to represent the patient's presumed will and interests as a surrogate consentee, taking into consideration the patient's family structure, circumstances, and other factors.
Key exclusion criteria
Those who did not agree to participate in this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Physiology/Memory center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
035363374
dito@keio.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Physiology/Memory center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
0353633747
Homepage URL
dito@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 05 | 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
0
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
| 2022 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood: Blood will be collected using normal blood collection techniques. The maximum amount of blood collected is expected to be 20 ml, and the likelihood of serious complications is very low.
Urine: 30-50 ml of urine should be collected in the middle of the day by autonomous voiding. If autonomous voiding is difficult, collect the voided urine with a urine pack. The collection of voided urine is noninvasive.
CSF: This is performed as part of the routine examination (approximately 15 ml collection). CSF is collected using the usual CSF collection technique. The total volume collected is expected to be 20 ml at the upper limit (approximately 5 ml for this study), and the likelihood of serious complications in the future is extremely low.
The above body fluids will be used for neurodegenerative disease biomarker measurements (plasma phosphorylated tau, NFL, GFAP, omics analysis, etc.).
The above fluid collections will be taken multiple times as the disease progresses.
Clinical information (interview, history, neurological findings, etc.) and laboratory data (images, blood samples, urine, cerebrospinal fluid, neuropsychological tests, etc.) within the normal course of general practice will be used for this study.
For iPS cell generation, reprogramming will be performed from lymphocytes and urine-derived cells according to the established method (Fujimori et al., 2018). iPS cell-derived neurons will be phenotyped (cell death markers, neurite outgrowth, etc.).
Excess specimens will be stored by the principal investigator in the Department of Physiology and used for future new biomarker studies.
Management information
Registered date
| 2023 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060135
