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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034832
Receipt No. R000039727
Official scientific title of the study Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective observational multi center study.
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/09

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Basic information
Official scientific title of the study Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective observational multi center study.
Title of the study (Brief title) A newly developed scoring system for detection of early pancreatic cancer: Observational study.
Region
Japan

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

Objectives
Narrative objectives1 Long-term 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
20 years-old <=
Age-upper limit
76 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, pancreatic duct dilation, and lobularity of pancreas on EUS.
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 3500

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

Public contact
Name of contact person Ryota Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
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)

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 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 09 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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