UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051816 |
|---|---|
| Receipt number | R000059120 |
| Scientific Title | Genomic profiling propriety of biliary tumor biopsy: multicenter prospective trial |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/03 15:21:07 |
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Basic information
Public title
Genomic profiling propriety of biliary tumor biopsy: multicenter prospective trial
Acronym
Genomic profiling of biliary biopsy
Scientific Title
Genomic profiling propriety of biliary tumor biopsy: multicenter prospective trial
Scientific Title:Acronym
Genomic profiling of biliary biopsy
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To reveal the suitability of biliary biopsy specimen for genome profiling in biliary tract cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Suitability of biliary biopsy specimen for genome profiling.The details are as follows.
10 unstained and one H&E-stained FFPE slides
The FFPE specimen surface area should be 25 mm2 or greater
When the FFPE specimen surface area is less than 25mm2, the total volume of specimen is 1 mm3 or greater.
The tumor cells should be 20% or more
Key secondary outcomes
The suitability of biliary biopsy specimen for NCC oncopanel.
Histology score
0: insufficient material for interpretation
1: sufficient material for limited cytological interpretation
2: sufficient material for adequate cytological interpretation
3: sufficient material for limited histological interpretation
4: sufficient material for adequate histological interpretation, low quality (total material < 10 power field length)
5: sufficient material for adequate histological interpretation, high quality (> 10 power field length)
Factors which are related to ERCP procedure
Adverse events
Maximum value of serum amylase until a week after ERCP
Maximum value of serum amylase pancreatic isozyme until a week after ERCP
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
Cases who were diagnosed as biliary tumor by echo, CT, MRI and who were performed biliary biopsy.
Key exclusion criteria
N/A
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology,Gastroenterology
Zip code
960-1295
Address
Hikarigaoka 1, Fukushima City, Fukushima Prefecture, Japan
TEL
0245471202
kita335@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
960-1295
Address
Hikarigaoka1, Fukushima City, Fukushima Prefecture, Japan
TEL
0245471202
Homepage URL
kita335@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Rosai Hospital, Fukushima Red Cross Hospital, Saiseikai Fukushima General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
Hikarigaoka1, Fukushima City, Fukushima Prefecture, Japan
Tel
0245471794
rs@fmu.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 | 08 | Month | 07 | 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 | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059120
