UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosis of cases of early recurrence after resection of pancreatic cancer
Acronym	Diagnosis of cases of early recurrence after resection of pancreatic cancer
Scientific Title	Development of a diagnostic method for high-risk cases of early postoperative recurrence of pancreatic cancer using temporal exosome analysis
Scientific Title:Acronym	Development of a diagnostic method for high-risk cases of early postoperative recurrence of pancreatic cancer using temporal exosome analysis
Region	Japan

Condition
Condition	pancreatic ductal adenocarcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	In this study, we will analyze microRNAs (miRs) encapsulated in exosomes over time before and after surgery and perioperative chemotherapy, and prospectively analyze the relationship between specific miRs, recurrence type, and prognosis to determine whether it is possible to predict high-risk cases of early postoperative recurrence of pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Identification of miRs associated with early recurrence
Key secondary outcomes	Relationship between candidate miRs and prognosis

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who have been or will be treated for pancreatic cancer at our hospital 2)Age 20 years or older 3) Patients who are able to collect new peripheral blood (10ml) 4) Patients who have sufficient judgment to understand the contents of the study and have given written consent.
Key exclusion criteria	None in particular
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Imamura
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	0608543
Address	South 1, West 16, Chuo-ku, Sapporo
TEL	0116112111
Email	imamura@sapmed.ac.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Imamura
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	0608543
Address	South 1, West 16, Chuo-ku, Sapporo
TEL	0116112111
Homepage URL
Email	imamura@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Sapporo Medical University Hospital
Address	South 1, West 16, Chuo-ku, Sapporo
Tel	0116112111
Email	rinri@sapmed.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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Results
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 05 Month 14 Day
Date of IRB	2020 Year 06 Month 11 Day
Anticipated trial start date	2020 Year 06 Month 11 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. Retrospective study of postoperative patients with pancreatic cancer We will perform a comprehensive analysis of miRs using microarrays on 5 recurrence cases and 5 recurrence-free cases (10 cases in total) to examine candidate genes. Based on the results, miR expression will be analyzed using the Realtime-PCR method to identify miRs associated with recurrence. 2. Prospective study of patients scheduled for resection of pancreatic cancer The expression of candidate miRs will be analyzed over time before and after surgery. Candidate miRs will be contrasted with clinical data (stage, presence of recurrence, recurrence type, and prognosis). To evaluate early recurrence, patients will be seen every month for 1 year after surgery, and blood tests including tumor markers (CEA, CA19-9, DUPAN2) will be performed every time. The relationship between candidate miRs and prognosis will be statistically analyzed using the Kaplan-Meier method and Cox proportional hazards model to verify whether early recurrence is predictable or not. Tumor markers and imaging are currently the only means to depict recurrence, but we will examine whether or not the candidate miRs in exosomes change prior to these tests.

Management information
Registered date	2021 Year 08 Month 10 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051535