UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective multi center study.
Acronym	A newly developed scoring system for detection of early pancreatic cancer.
Scientific Title	Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective multi center study.
Scientific Title:Acronym	A newly developed scoring system for detection of early pancreatic cancer.
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of newly developed scoring system for detection of early pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of pancreatic cancer and early pancreatic cancer less than 10 mm in diameter.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Perform of Endoscopic ultrasound Perform of Endoscopic ultrasound according to cases
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	18 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with 3 risk factors or more, sporadic family history of pancreatic cancer, diabetes, alcohol 37.5g/day, smoking, obesity, stomach symptoms or back pain, weight loss, diabetes exacerbation, and increase in pancreatic enzyme. The patients with 1 risk factor or more, new onset of diabetes, familial pancreatic cancer, jaundice, increase in tumor markers, chronic pancreatitis, intraepithelial pancreatic mucinous neoplasm, pancreatic cyst, hereditary pancreatic cancer syndrome, hereditary pancreatitis, and pancreatic duct dilation.
Key exclusion criteria	Cases in which pancreatic cancer is strongly suspected by other image modality before screening. Cases in which pancreatic screening had been already performed and followed. When informed consent can not be obtained.
Target sample size	3500

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
Zip code	2702232
Address	1271 Wanagaya, Matsudo Chiba, Japan
TEL	0477118700
Email	sagami1985@yahoo.co.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
Zip code	2702232
Address	1271 Wanagaya, Matsudo Chiba, Japan
TEL	0477118700
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	New Tokyo Hospital
Institute
Department

Funding Source
Organization	None
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	New Tokyo Hospital
Address	1271 Wanagaya, Matsudo Chiba, Japan
Tel	0477118700
Email	sagami1985@yahoo.co.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	2018 Year 06 Month 21 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	Completed
Date of protocol fixation	2018 Year 11 Month 09 Day
Date of IRB	2018 Year 02 Month 25 Day
Anticipated trial start date	2018 Year 06 Month 21 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 21 Day
Last modified on	2019 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037734