臨床研究等提出・公開システム

Date of registration	July. 14, 2023
Last modified on	Nov. 03, 2023
Trial ID	jRCT1030230227

Scientific Title	A prospective cohort observational study for the development of exosome monitoring marker in pancreatic cancer
Public Title	The development of exosome monitoring marker in pancreatic cancer

Contact for Scientific Queries	Name	Nana Shimamoto
	Affiliation	The Jikei University School of Medicine
	Address	3-25-8
	Telephone	+81-7039141093
	E-mail	nanahachinetyou@gmail.com
Contact for Public Queries	Name	Nana Shimamoto
	Affiliation	The Jikei University School of Medicine
	Address	3-25-8
	Telephone	+81-7039141093
	E-mail	nanahachinetyou@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 14, 2023
Actual date of first enrollment		Oct. 13, 2023
Target sample size		280
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Individuals who was diagnosed with pancreatic cancer and untreated. (2) Individuals who attend the hospital under the diagnosis of the benign pancreatic disease. (3)Individuals who did not have a pancreatic cancer or the benign pancreatic tumor and visit Jikei medical chekup center. (4) Individuals aged 20 and over.
	Exclusion Criteria	(1) Individuals who declined to participate in the research. (2) Individuals who are pregnant.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		pancreatic cancer, pancreatic benign disease (chronic pancreatitis, IPMN)
Health Condition(s) Keyword		pancreatic cancer, exosome
Health Condition(s) Code		D010190, D050500, D000077779
Primary Outcome(s)		Difference in the amount of exosomes at the baseline among the pancreatic cancer, benign pancreatic disease and healthy control.
Secondary Outcome(s)		1) Difference in the change in exosome levels before and after chemotherapy between the chemotherapy responsive and non-responsive groups. 2) Quantitative evaluation of the difference in exosome protein immunohistochemical staining (IHC) of FNA and surgical specimens between the chemotherapy responsive and non-responsive groups. 3) Difference in the exosome level compared at the baseline and at the reccurence.

Primary Sponsor	Senya Matsufuji

Name of Certified Review Board	The Jikei University Certified Review Board
Address	3-25-8, Tokyo
Telephone	+81-3-3433-1111
Approval Status	Approval
Date of approval	Mar. 06, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Nov. 03, 2023	(this page)	Changes
1	July. 14, 2023	Detail

List of change history