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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031969
Receipt No. R000036459
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-
Date of disclosure of the study information 2018/03/29
Last modified on 2020/03/31

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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 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 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
2020 Year 03 Month 31 Day


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

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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