UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031969 |
|---|---|
| Receipt number | 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 | 2021/03/30 09:10:40 |
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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
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
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita San-ai Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036459
