NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042210083

Registered date:12/10/2021

A prospective, randomized, non-comparative trial to explore the optimal methods of EUS-FNB for multiple-gene panel test

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedpancreatic cancer
Date of first enrollment11/11/2021
Target sample size75
Countries of recruitment
Study typeInterventional
Intervention(s)endoscopic ultrasound-guided fine needle biopsy

Outcome(s)

Primary OutcomePercentage of candidate samples for NGS
Secondary OutcomeTumor area on a slide Accuracy rate of EUS-FNB Success rate of predetermined number of needle passes Rate of successful of one needle pass The number of needle passes Procedure time Adverse events during EUS-FNB Post-procedure adverse events Rate of passed or qualified report in patients who undergo F1CDx Rate of passed report in patients who undergo F1CDx Tumor area on a slide in patients who undergo F1CDx

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum<= 80age old
GenderBoth
Include criteria1)Patient with suspected pancreatic malignant tumor Patient with no indication of radical resection 2)Patient <=80 years 3)Patient scheduled to have a genetic panel test using tumor tissue 4)Patient with performance status <=1 according to the ECOG standard. 5)Patient with no severe disorders in major organs 6)Written informed consent
Exclude criteria1) Patient with history of radiation therapy or chemotherapy for pancreatic cancer. 2) Patient with the regular use of antithrombotic drugs that cannot be suspended during EUS-FNB 3) Patient with mental disorder 4) Inappropriate patient for the study

Related Information

Contact

Public contact
Name Junya Sato
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ju.sato@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Junya Sato
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ju.sato@scchr.jp
Affiliation Shizuoka Cancer Center