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Genomic profiling propriety of biliary tumor biopsy: multicenter prospective trial

Genomic profiling propriety of biliary tumor biopsy: multicenter prospective trial - Genomic profiling of biliary biopsy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051816
Enrollment
88
Registered
2023-08-07
Start date
2023-08-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer

Interventions

None listed

Sponsors

Fukushima Medical University
Lead Sponsor
Fukushima Rosai Hospital, Fukushima Red Cross Hospital, Saiseikai Fukushima General Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases who were diagnosed as biliary tumor by echo, CT, MRI and who were performed biliary biopsy.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMitsuru Sugimoto

Fukushima Medical University Department of Gastroenterology

kita335@fmu.ac.jp0245471202

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026