UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053300 |
|---|---|
| Receipt number | R000060836 |
| Scientific Title | Endoscopic trans-papillary biliary biopsy for genomic panel testing in cholangiocarcinoma |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/09 17:40:05 |
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Basic information
Public title
Endoscopic trans-papillary biliary biopsy for genomic panel testing in cholangiocarcinoma
Acronym
Endoscopic trans-papillary biliary biopsy for genomic testing
Scientific Title
Endoscopic trans-papillary biliary biopsy for genomic panel testing in cholangiocarcinoma
Scientific Title:Acronym
Endoscopic trans-papillary biliary biopsy for genomic testing
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether endoscopic trans-papillary bile duct biopsy can provide an adequate specimen for genomic panel testing in patients with cholangiocarcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adequacy for genomic panel testing using endoscopic bile duct biopsy
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
1. Patients with 20 years or older at the time of participation in the study.
2. Patients who are suspected of cholangiocarcinoma from image testing and who are planned to undergo endoscopic biliary biopsy for diagnosis.
Key exclusion criteria
1. Patients with prothrombin time < 50% or platelet count < 50000/mm3.
2. Patients who are taking more than 2 antithrombotic drugs.
3. Patients with a history of gastrectomy other than Billroth 1.
4. Patients with gastrointestinal stenosis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kuraishi |
Organization
Shinshu university school of medicine
Division name
Department of gastroenterology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-35-4600
yasuhiro@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kuraihsi |
Organization
Shinshu university school of medicine
Division name
Department of gastroenterology
Zip code
390-8621
Address
3-1-1, Asahni, Matsumoto, Nagano, Japan
TEL
0263354600
Homepage URL
yasuhiro@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu university school of medicine
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-35-4600
yasuhiro@shinshu-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
| 2024 | Year | 01 | Month | 10 | 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 | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060836
