UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049915 |
|---|---|
| Receipt number | R000056853 |
| Scientific Title | An exploratory prospective study of the relationship between duodenal cancer and Lynch syndrome |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/08/07 13:58:00 |
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Basic information
Public title
An exploratory prospective study of the relationship between duodenal cancer and Lynch syndrome
Acronym
An exploratory prospective study of the relationship between duodenal cancer and Lynch syndrome
Scientific Title
An exploratory prospective study of the relationship between duodenal cancer and Lynch syndrome
Scientific Title:Acronym
An exploratory prospective study of the relationship between duodenal cancer and Lynch syndrome
Region
| Japan |
Condition
Condition
duodenal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate how many patients with duodenal cancer are included in the Lynch syndrome
Basic objectives2
Others
Basic objectives -Others
Patients with duodenal cancer as a result of endoscopic treatment will be examined for microsatellite instability and mismatch repair gene mutations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of Lynch Syndrome in patients with duodenal cancer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with duodenal cancer after endoscopic resection, 20 years of age or older
Key exclusion criteria
Cases in which the subject is incapable of consenting due to dementia, etc.
Cases in which the subject refuses to participate in the study after enrollment
Other cases that the doctor judges that the subject is not suitable for enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Minezaki |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
d-mine@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 if Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
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 | 01 | 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 | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe whether patients with duodenal cancer as a result of endoscopic treatment are diagnosed with Lynch Syndrome at subsequent additional examinations.
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
