UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039623 |
|---|---|
| Receipt number | R000045193 |
| Scientific Title | Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/04/27 20:21:29 |
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Basic information
Public title
Evalutation of the patients with localized stricture of MPD without obvious mass in the pancreas
Acronym
Pancreatic cancer study
Scientific Title
Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer
Scientific Title:Acronym
Study for the early detection of pancreatic cancer
Region
| Japan |
Condition
Condition
Patients with localized MPD stricture without obvious mass in pancreas
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to find new imaging findings leading to the early detection of pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reading computed tomography, magnetic resonance imaging, and endoscopic ultrasonography image.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with MPD stricture
Key exclusion criteria
Patients with obvious pancreatic mass
Patients with chronic pancreatitis
Patients with post pancreatic surgery
Patients with pancreatic injury
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kurita |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name
Department of Gastroenterology and Hepatology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL
06-6131-2662
kuritaaki1976@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kurita |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Division name
Department of Gastroenterology and Hepatology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6131-2662
Homepage URL
kuritaaki1976@gmail.com
Sponsor or person
Institute
Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kitano Hospital
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
Tel
06-6131-2662
rinshou@kitano-hp.or.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
公益財団法人田附興風会医学研究所北野病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective analysis
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045193
