Genomic profiling propriety of biliary tumor biopsy: multicenter prospective trial
Not Applicable
Recruiting
- Conditions
- Biliary tract cancer
- Registration Number
- JPRN-UMIN000051816
- Lead Sponsor
- Fukushima Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
Not provided
Exclusion Criteria
N/A
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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