UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052808 |
|---|---|
| Receipt number | R000060159 |
| Scientific Title | Prospective observational study of factors contributing to the incidence of Fontan associated liver disease (FALD) and fibrosis after Fontan procedure |
| Date of disclosure of the study information | 2023/11/16 |
| Last modified on | 2023/11/15 22:35:36 |
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Basic information
Public title
Prospective observational study of factors contributing to the incidence of Fontan associated liver disease (FALD) and fibrosis after Fontan procedure
Acronym
Prospective observational study of Fontan associated liver disease
Scientific Title
Prospective observational study of factors contributing to the incidence of Fontan associated liver disease (FALD) and fibrosis after Fontan procedure
Scientific Title:Acronym
Prospective observational study of FALD
Region
| Japan |
Condition
Condition
Fontan associated liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify factors contributing to FALD morbidity and fibrosis.
Basic objectives2
Others
Basic objectives -Others
Exploratory analysis of factors contributing to hepatocellular carcinoma incidence, survival, fibrosis, carcinogenesis, and survival (various biochemical tests, fibrosis score, MR elastography, ultrasound elastography, and liver parenchymal contrast time on contrast abdominal ultrasound)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of liver fibrosis after Fontan surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. postoperative patients after Fontan procedure
2. patients who are outpatients or hospitalized in our hospital
3. Patients who are at least 18 years of age at the time of consent, regardless of gender.
4. Patients who can provide written consent to participate in this study.
Key exclusion criteria
Patients deemed unsuitable by the principal investigator or principal investigator to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Taniki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nobuhitotaniki@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku,Tokyo
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 | 16 | 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
| 2023 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2033 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, blood, image, pathology, and other laboratory test results obtained from patients in the target population during the observation period will be extracted from their medical records and analyzed.
Blood
1) Approximately 16 mL of blood should be collected in addition to the usual examination.
2) Separate blood cells, serum or plasma. Peripheral blood lymphocytes within blood cells are separated by specific gravity centrifugation, and immune cell fractions of T cells, B cells, macrophages, and dendritic cells are analyzed using flow cytometry. Analyze antigens/antibodies, proteins, peptides, and low molecular weight compounds in serum or plasma.
Feces
1) Collect approximately 20 g of feces.
2) Mix 10 ml of saline solution per 1 g of feces and filter it through a mesh.
3) Comprehensive analysis of the intestinal microflora will be performed on the processed fecal specimens. A portion of the samples will be orally administered to sterile mice to examine their direct involvement in the disease.
4) Some of the specimens will be stored frozen.
Liver specimens
1) Tissues that will not affect the histopathological examination will be collected from patients undergoing hepatectomy and liver tissue biopsy according to medical necessity.
2) Extract DNA, RNA, immune cells, etc. from the collected tissue. In addition, DNA will be extracted from blood samples as a reference of the patient's normal genome. The obtained DNA will be subjected to comprehensive genomic analysis using a next-generation sequencer to examine differences in genetic variation from the blood DNA. The obtained RNA will be subjected to gene expression analysis by RT-PCR, microarray, and RNA-Seq methods. Genomic analysis of DNA that may identify individuals will not be performed. Immune cells will be analyzed by flow cytometry.
3) Additional immunostaining will be included in pathology.
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=R000060159
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