UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034832 |
|---|---|
| Receipt number | R000039727 |
| Scientific Title | Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective multi center observational study. |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2020/05/11 09:06:17 |
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Basic information
Public title
Evaluation of a newly developed scoring system for detection of early pancreatic cancer: A prospective multi center observational 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 observational 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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with one or more risk factors; 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, 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 or pancreatobiliary screening.
For above reasons, patients is performed endoscopic ultrasound examination.
The patients with performance status 1 or 2.
When informed consent about this study can be obtained.
When pancreatic cancer is detected, the patients can be performed the invasive examination or operation, and histological diagnosis can be obtained.
Key exclusion criteria
Patients in which pancreatic cancer is strongly suspected by other image modality before screening.
When informed consent can not be obtained.
Target sample size
7000
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
870-1151
Address
Oaza Ichi 1213, Oita, Oita 870-1151, Japan.
TEL
+81-97-541-1311
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
870-1151
Address
Oaza Ichi 1213, Oita, Oita 870-1151, Japan.
TEL
0477118700
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
Oaza Ichi 1213, Oita, Oita 870-1151, Japan.
Tel
+81-97-541-1311
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
・JA尾道総合病院(広島県)
・大分大学医学部附属病院(大分県)
・大分三愛メディカルセンター(大分県)
・大阪国際がんセンター(大阪府)
・岡波総合病院(三重県)
・川崎医科大学附属病院(岡山県)
・九州大学大学院医学研究院(福岡県)
・島根大学医学部附属病院(島根県)
・がん・感染症センター都立駒込病院(東京都)
・福岡大学筑紫病院(福岡県)
・南和歌山医療センター(和歌山県)
・岸和田徳洲会病院(大阪府)
・国立国際医療研究センター国府台病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | 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 | 11 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When first examination is performed, the relation risk factors, scores and detection of pancreatic cancer is cofirmed.
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039727
