JPRN-jRCTs051230169
Not yet recruiting
未知
Investigation of the usefulness of a screening test for pancreatic cancer based on highly sensitive detection of gene mutations in duodenal juice collected using synthetic human secretin and a specially made catheter following conventional esophagogastroduodenoscopy in high-risk individuals
Shinich Yachida0 sites300 target enrollmentJanuary 25, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Persons at high risk of pancreatic cancer
- Sponsor
- Shinich Yachida
- Enrollment
- 300
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Men and women aged 18 years or older at the time of consent acquisition
- •2\) Subjects diagnosed as high\-risk in a prospective cohort (Onomichi Cohort, Matsue Cohort, National Cancer Cohort, Osaka International Cancer Center Cohort, Tottori University Cohort, Wakayama Medical University Cohort, Aichi Cancer Center Cohort) and undergo EUS (endoscopic ultrasound) examination.
- •3\) Written consent to participate in this study has been obtained from the subject
Exclusion Criteria
- •1\) Subjects with hypersensitivity to secretin or other ingredients (excipients: cysteine hydrochloride and mannitol)
- •2\) Subjects within two weeks of remission from acute exacerbation of acute pancreatitis or chronic pancreatitis
- •3\) Subjects who cannot take anticholinergic drugs for five half\-lives before endoscopy
- •4\) Pregnant or lactating women
- •5\) Subjects who have received other study or investigational drugs within three months prior to the start of study drug administration
- •6\) Subjects who are difficult to observe the duodenal papilla (e.g., postoperative patients)
- •7\) Patients with suspected or diagnosed conventional pancreatic cancer or intraductal papillary mucinous tumor at registration
- •8\) Other Subjects who are deemed inappropriate by the principal investigator
Outcomes
Primary Outcomes
Not specified
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