UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052453 |
|---|---|
| Receipt number | R000059870 |
| Scientific Title | A study to evaluate the efficacy of the fecal elastase-1 (FE-1) test kit (provisional name) by immunochromatographic assay in diagnosis for pancreatic exocrine insufficiency. |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2024/09/03 11:42:14 |
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Basic information
Public title
A study to evaluate the efficacy of the fecal elastase-1 test kit in diagnosis for pancreatic exocrine insufficiency.
Acronym
Clinical performance test of FE-1 Quick test
Scientific Title
A study to evaluate the efficacy of the fecal elastase-1 (FE-1) test kit (provisional name) by immunochromatographic assay in diagnosis for pancreatic exocrine insufficiency.
Scientific Title:Acronym
Clinical performance test of FE-1 Quick test
Region
| Japan |
Condition
Condition
Pancreatic exocrine insufficiency
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and clinical performance of ScheBo Pancreas Elastase 1 Quick test as an auxiliary diagnostic test for pancreatic exocrine insufficiency.
Basic objectives2
Others
Basic objectives -Others
the efficacy and the clinical performance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive concordance rate, negative concordance rate and total concordance rate of the results between ScheBo Pancreas Elastase 1 Quick test and the control assay
Key secondary outcomes
Not set.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who consent to participate in this study, and patients that their legal representatives give consent on behalf of children in case that they are under 18 years of age.
Key exclusion criteria
Patients who judged ineligible by investigators
Target sample size
164
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Asami |
Organization
Viatris Pharmaceuticals Japan Inc.
Division name
Medical Affairs Japan
Zip code
105-0001
Address
Holland Hills Mori Tower, 5-11-2 Toranomon, Minato-ku, Tokyo
TEL
03-5656-0400
yuko.asami@viatris.com
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Saito |
Organization
RIKEN Genesis Co., Ltd.
Division name
Drug Development Support Office
Zip code
141-0032
Address
1-2-2 Osaki, Shinagawa-ku, Tokyo
TEL
03-5759-6041
Homepage URL
RGK-fe1q@rikengenesis.jp
Sponsor or person
Institute
Viatris Pharmaceuticals Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Kindai University Hospital, Secretariat of Clinical Research Advance Review Committee
Address
Kindai University Hospital, 377-2, Ohnohigashi, Osaka-Sayama, Osaka, Japan
Tel
072-366-0221
zizen@med.kindai.ac.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
| 2023 | Year | 10 | Month | 10 | 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
214
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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 17 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 10 | Day |
Other
Other related information
Method of recruitment of subjects: patients who visited the study site between October 2023 and March 2024, whose physicians suspected pancreatic exocrine insufficiency and who met the selection exclusion criteria.
Management information
Registered date
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059870
