UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052118 |
|---|---|
| Receipt number | R000059489 |
| Scientific Title | Unraveling the effect of clonal hematopoiesis in the progression of abdominal aortic aneurysms |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2024/09/13 12:00:46 |
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Basic information
Public title
Research to elucidate the association between acquired genetic mutations and abdominal aortic aneurysms
Acronym
Research to elucidate the association between acquired genetic mutations and abdominal aortic aneurysms
Scientific Title
Unraveling the effect of clonal hematopoiesis in the progression of abdominal aortic aneurysms
Scientific Title:Acronym
Unraveling the effect of clonal hematopoiesis in the progression of abdominal aortic aneurysms
Region
| Japan |
Condition
Condition
abdominal aortic aneurysms
Classification by specialty
| Cardiology | Vascular surgery | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to create a database of patients with abdominal aortic aneurysms and conduct a prospective observational study to determine the impact of clonal hematopoiesis on disease severity and treatment response in patients with abdominal aortic aneurysms.
Basic objectives2
Others
Basic objectives -Others
This study aims to elucidate the relationship between clonal hematopoiesis and abdominal aortic aneurysms and to elucidate a new pathogenic mechanism of abdominal aortic aneurysms. Depending on the results of the research, it may lead to the foundation for the development of precision medicine for abdominal aortic aneurysms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients with clonal hematopoiesis at initial surgical admission for abdominal aortic aneurysm
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 scheduled for initial surgery for abdominal aortic aneurysm at Nagoya University Hospital
Key exclusion criteria
Inflammatory/infected/dissected abdominal aortic aneurysms are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | yoshimitsu |
| Middle name | |
| Last name | yura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-0388
y.yura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | jun |
| Middle name | |
| Last name | yonekawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-0388
Homepage URL
yonekawa.jun.b1@s.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Nagoya University Graduate School of Medicine, Graduate School of Medicine
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-0388
y.yura@med.nagoya-u.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 | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | 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
Prospective cohort study, all patients who visited our clinic from the date of Ethics Review Board approval to March 31, 2025 and meet the selection criteria, genes of interest: DNMT3A, TET2, ASXL1, PPM1D, JAK2, SF3B1, SRSF2, TP53, CALR, MPL, ATM, CHEK2, EZH2, GNB1, PHF6, RUNX1, SMC1A, BCOR, BCORL1, BRAF, BRCC3, CBL, CSF1R, FLT3, GNAS, GNB1, IDH1, IDH2, KDM6A, KIT, KRAS, MYD88, NPM1, NRAS, PIGA, PRPF40B, RAD21, RUNX1, SF1, SF3A1, SMC3, STAG2, STAT3, U2AF1, U2AF2, ZRSR2
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059489
