UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039298 |
|---|---|
| Receipt number | R000044766 |
| Scientific Title | Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE) for pancreatic carcinoma in situ |
| Date of disclosure of the study information | 2020/01/29 |
| Last modified on | 2020/03/27 14:12:33 |
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Basic information
Public title
Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE) for pancreatic carcinoma in situ
Acronym
Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE)
Scientific Title
Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE) for pancreatic carcinoma in situ
Scientific Title:Acronym
Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE)
Region
| Japan |
Condition
Condition
Pancreatic carcinoma in situ
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We reveal the efficacy of the SPACE for the diagnosis of the pancreatic carcinoma in situ.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of pancreatic juice cytology.
Key secondary outcomes
The evaluation of the image findings suggesting the pancreatic carcinoma in situ.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The pancreatic duct dilation, pancreatic duct stenosis, focal pancreatic atrophy and fatty change either CT, MRI or EUS.
2) Written informed consent.
Key exclusion criteria
1)Unachievable ERCP due to difficult cannulation.
2)Unachievable ERCP due to post-abdominal surgery state including gastrectomy.
3)Inappropriate patients for study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sawako |
| Middle name | |
| Last name | Kuruma |
Organization
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
TEL
03-3823-2101
sawako@cick.jp
Public contact
Name of contact person
| 1st name | Sawako |
| Middle name | |
| Last name | Kuruma |
Organization
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
TEL
03-3823-2101
Homepage URL
sawako@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Address
3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
Tel
03-3823-2101
rinri@cick.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
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prognosis of pancreatic cancer is poor, but the prognosis is better if diagnosed at the stage of pancreatic carcinoma in situ. We expect the diagnosis of pancreatic carcinoma in situ will improve by serial pancreatic-juice aspiration cytologic examination (SPACE).
Management information
Registered date
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044766
