UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053829 |
|---|---|
| Receipt number | R000061431 |
| Scientific Title | Mapping biopsy to assess the superficial ductal spread of the biliary tract cancer |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/03/11 15:57:14 |
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Basic information
Public title
Mapping biopsy to assess the superficial ductal spread of the biliary tract cancer
Acronym
Mapping biopsy to assess the superficial ductal spread of the biliary tract cancer
Scientific Title
Mapping biopsy to assess the superficial ductal spread of the biliary tract cancer
Scientific Title:Acronym
Mapping biopsy to assess the superficial ductal spread of the biliary tract cancer
Region
| Japan |
Condition
Condition
Cases of biliary tract cancer with mapping biopsy to evaluate the superficial ductal spread before surgical resection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of mapping biopsy for diagnosing superficial ductal spread before surgical resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the accuracy of mapping biopsy for diagnosing superficial ductal spread before surgical resectio
Key secondary outcomes
The accuracy of mapping biopsy (under POCS, with/without Endosheather)
The adverse events
The efficacy of surgical treatment
The comparison of biopsy and surgical specimens
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
>19-years-old
The resectable biliary tract cancer case
Key exclusion criteria
The patients who did not undergo endoscopic diagnosis or the mapping biopsy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunami General Hospital
Division name
Department of Gastroenterology
Zip code
5016062
Address
Tashiro 185-1, Kasamatu cho, Hashima Gun, Gifu pref.
TEL
058-388-0111
mkobdkl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunami General Hospital
Division name
Department of Gastroenterology
Zip code
5016062
Address
Tashiro 185-1, Kasamatu cho, Hashima Gun, Gifu pref.
TEL
0583880111
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Matsunami General Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsunami General Hospital
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
Matsunami General Hospital
Address
Tashiro 185-1, Kasamatu cho, Hashima Gun, Gifu pref.
Tel
058-388-0111
mkobdkl@yahoo.co.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 | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 01 | 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 | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061431
