UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052804 |
|---|---|
| Receipt number | R000060262 |
| Scientific Title | Mitochondrial preemptive medicine |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/15 13:55:24 |
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Basic information
Public title
Mitochondrial preemptive medicine
Acronym
Mitochondrial medicine
Scientific Title
Mitochondrial preemptive medicine
Scientific Title:Acronym
Mitochondrial medicine
Region
| Japan |
Condition
Condition
Parkinson's disease, Alzheimer's disease, depression, cancer, hearing loss, inflammatory bowel disease, ALS and other neurological disorders, hypertension, diabetes, renal disease
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Endocrinology and Metabolism | Nephrology |
| Neurology | Psychosomatic Internal Medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Endocrine surgery | Breast surgery |
| Pediatrics | Psychiatry | Oto-rhino-laryngology |
| Orthopedics | Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This research will elucidate the pathogenesis of mitochondria-related diseases and develop treatment and in vitro diagnostic methods.
Basic objectives2
Others
Basic objectives -Others
Abnormal mitochondrial function may lead to several diseases, including cancer.
Recently, it has become clear that the intestinal microbiota and mitochondria mutually regulate host functions through metabolites; however, there is still uncertainty.
Blood, saliva, stool, urine, exhaled breath, and tissue samples will be collected from patients attending several hospitals. The same samples will also be collected from healthy subjects recruited from the public.
We will analyze the clinical data of the patients, basic information of the healthy subjects, whole genome analysis, epigenome analysis, transcriptome analysis, metabolome analysis of various metabolites, fecal culture and metagenome analysis, metatranscriptome analysis, and proteome analysis of the collected specimens.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will analyze the clinical data of the patients and basic information of the healthy subjects, whole genome analysis, epigenome analysis, transcriptome analysis, metabolome analysis of various metabolites, fecal culture and metagenome analysis, metatranscriptome analysis, and proteome analysis of the collected specimens.
Key secondary outcomes
Patient and healthy subject data will be compared with Tohoku Medical Megabank Organization data (three-generation cohort and enterobacterial cohort).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a clinical diagnosis or confirmed by previous clinical or genetic diagnosis that they have the target disease diagnosed at Tohoku University, Chiba Children's Hospital, Chiba Cancer Center, Konan Hospital, Juntendo University Hospital, Saitama Medical University Hospital, Nagasaki University Hospital, and National Cardiovascular Center are eligible.
Key exclusion criteria
Patients will be excluded from the study if consent from the patient or the patient's family cannot be obtained.
Target sample size
6284
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Abe |
Organization
Tohoku Univerisity, Graduate School of Biobedical Engineering
Division name
Division of Medical Science
Zip code
980-8564
Address
1-1 Seiryo-machi, Aoba-Ward, Sendai, Miyagi, Japan
TEL
022-717-7200
mitomoonshot@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Abe |
Organization
Tohoku Univerisity, Graduate School of Biobedical Engineering
Division name
Division of Medical Science
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-Ward, Sendai, Miyagi, Japan
TEL
022-717-7200
Homepage URL
mitomoonshot@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 12 | 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
| 2021 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the relationship between various diseases and mitochondrial function by performing a multi-omics analysis that stores clinical information and multi-omics data obtained from clinical specimens of the target diseases.
In this study, target diseases requiring intervention with drugs that improve mitochondrial function will be selected.
In addition, we will develop a sensor to non-invasively evaluate mitochondrial function from outside the body.
Management information
Registered date
| 2023 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060262
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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