Examination of the cancer genomic profiling test using bile cell block specimens and bile cytology specimens in malignant biliary tract disease

JRCT ID: jRCT1042230129

Registered date:11/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant biliary stricture (biliary tract cancer, pancreatic cancer)
• Date of first enrollment: 16/09/2022
• Target sample size: 80
• Study type: Observational

Outcome(s)

• Primary Outcome: Success rate and accuracy of cancer gene analysis using bile samples

Secondary Outcome

Quantity and quality of DNA
The relationship between cancer gene analysis and anticancer drug
Factors for accurate cancer gene analysis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age > 19 years
2. The patients who was able to place ENBD or PTBD, and collect bile for cytology and cell block method
3. The case with written informed consent for participation

Exclude criteria

1. The patients who was not able to place ENBD or PTBD
2. The patients who were already diagnosed cytologically or histologically before this study
3. The patients who are otherwise judged by the investigator to be ineligible to participate in the study

Related Information

• Primary Sponsor: Mitsuru Okuno
• Secondary Sponsor: Masahito Shimizu