臨床研究等提出・公開システム

Date of registration	Mar. 11, 2021
Last modified on	Mar. 11, 2021
Trial ID	jRCT1030200410

Scientific Title	Development and validation of serum microRNA panel for precise diagnosis of pancreatobiliary cancer
Public Title	Development of serum microRNA panel in pancreatobiliary cancer

Contact for Scientific Queries	Name	Mitsunaga Shuichi
	Affiliation	Natinonal Cancer Center Hospital East, Kashiwa
	Address	6-5-1 Kashiwanoha Kashiwa Chiba
	Telephone	+81-4-7133-1111
	E-mail	smitsuna@east.ncc.go.jp
Contact for Public Queries	Name	Miyazawa Shoichi
	Affiliation	Natinonal Cancer Center Hospital East, Kashiwa
	Address	6-5-1 Kashiwanoha Kashiwa Chiba
	Telephone	+81-4-7133-1111
	E-mail	smiyazaw@east.ncc.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 18, 2021
Actual date of first enrollment		Feb. 24, 2021
Target sample size		1325
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with clinical diagnose of pancreatic cancer or biliary truct cancer, who has not been treated. Patients who has been scheduled for the pathological diagnossis No other mallignant carcinoma
	Exclusion Criteria	None
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pancreatic cancer, biliary tract cancer
Health Condition(s) Keyword		Pancreatic cancer, biliary tract cancer
Health Condition(s) Code		C535836
Primary Outcome(s)		Sensitivity, Specificity, area under the receiver operating characteristic curve: AUC
Secondary Outcome(s)		Positive Predictive Value: PPV, Negative Predictive Value: NPV

Primary Sponsor	Toray Industries, Inc.

Source of Monetary Support / Secondary Sponsor	Toray Industries, Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	6-5-1 Kashiwanoha Kashiwa, Chiba
Telephone	+81-4-7133-1111
E-Mail	ncche-irb@east.ncc.go.jp
Approval Status	Approval
Date of approval	Feb. 03, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none