UMIN-CTR Clinical Trial

Basic information
Public title	A Novel diagnostic method using methylation of the cysteine dioxygenase 1 gene promoter DNA-Establishment of pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Acronym	A prospective case series study on pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Scientific Title	A Novel diagnostic method using methylation of the cysteine dioxygenase 1 gene promoter DNA-Establishment of pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Scientific Title:Acronym	A prospective case series study on pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Region	Japan

Condition
Condition	Pancreatic ductal adenocarcinoma
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of pancreatic fuluid cytology by detecting CDO1 gene methylation in patients for pancreatic ductal adenocarcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concordance rate between conventional cytology and DNA cytology
Key secondary outcomes	Concordance rate between histological diagnosis and DNA cytology

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
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients suspected with pancreatic ductal adenocarcinoma 2) Patients who had a high-risk factor of PDAC including chronic pancreatitis of pancreatic ductal adenocarcinoma 3) Patients who underwent ERP for a definitive diagnosis of the pancreatic ductal adenocarcinoma. 4) Patients who underwent endoscopic EUS-FNA for a definitive diagnosis of the pancreatic ductal adenocarcinoma. 5) With written informed consent before examination
Key exclusion criteria	Patients without preoperative informed consent
Target sample size	350

Research contact person
Last name of lead principal investigator	1st name Masahiko Middle name Last name Watanabe
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
Zip code	252-0374
Address	1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Email	gekaw@med.kitasato-u.ac.jp

Public contact
1st name of contact person	1st name Nobuyuki Middle name Last name Nishizawa
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
Zip code	252-0374
Address	1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Homepage URL
Email	dm14018v@st.kitasato-u.ac.jp

Sponsor
Institute	Department of Surgery, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Kitasato University School of Medicine
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	Kitasato University School of Medicine Ethics Committee
Address	1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
Tel	042-778-8111
Email	rinri@med.kitasato-u.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	2019 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 14 Day
Date of IRB	2016 Year 11 Month 14 Day
Anticipated trial start date	2016 Year 11 Month 21 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: A prospective case series study

Management information
Registered date	2019 Year 04 Month 04 Day
Last modified on	2019 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041483