UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective study.-The detection of stage 0 pancreatic cancer-
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 study.-The detection of stage 0 pancreatic cancer-
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	The detection rate of pancreatic cancer, especially, stage 0 and early pancreatic cancer less than 10 mm in diameter.
Key secondary outcomes	The relationship between each risk factor, clinical symptoms, score and diagnosis for pancreatic cancer. Characteristics of stage 0 pancreatic cancer.

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	Device,equipment Maneuver Other
Interventions/Control_1	Screening by endoscopic ultrasound
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	90 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. When informed consent can not be obtained.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	8701151
Address	Oaza Ichi 1213, Oita, Oita, Japan
TEL	0975411311
Email	sagami1985@yahoo.co.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	8701151
Address	Oaza Ichi 1213, Oita, Oita, Japan
TEL	0975411311
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	Oita San-ai Medical Center
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	Oita San-ai Medical Center
Address	1213 Oaza Ichi, Oita, Oita, Japan
Tel	0975411311
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 03 Month 29 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	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 03 Month 26 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 07 Month 16 Day
Date of closure to data entry	2019 Year 07 Month 16 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036459