UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049985 |
|---|---|
| Receipt number | R000056896 |
| Scientific Title | Proposed cut-off CA19-9 values for detection of pancreatic cancer in patients with poorly glycemic controlled diabetes: a real-world study |
| Date of disclosure of the study information | 2023/01/07 |
| Last modified on | 2024/01/09 12:01:00 |
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Basic information
Public title
Proposed cut-off CA19-9 values for detection of pancreatic cancer in patients with poorly glycemic controlled diabetes: a real-world study
Acronym
Proposed cut-off CA19-9 values for detection of pancreatic cancer in patients with poorly glycemic controlled diabetes: a real-world study
Scientific Title
Proposed cut-off CA19-9 values for detection of pancreatic cancer in patients with poorly glycemic controlled diabetes: a real-world study
Scientific Title:Acronym
Proposed cut-off CA19-9 values for detection of pancreatic cancer in patients with poorly glycemic controlled diabetes: a real-world study
Region
| Japan |
Condition
Condition
diabetes mellitus, pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine cut-off CA19-9 values for detection of pancreatic cancer in poorly glycemic controlled patients with diabetes, and its sensitivity and specificity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in CA19-9 values between patients with and without pancreatic cancer among patients with poorly glycemic controlled diabetes
Key secondary outcomes
Cut-off CA19-9 values for detection of pancreatic cancer in poorly glycemic controlled patients with diabetes, and its sensitivity and specificity
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
Inpatients with diabetes mellitus
Patients with measured CA19-9 level
Patients who have undergone abdominal echocardiography or abdominal CT
Patients who could be evaluated for pancreatic cancer by examining abdominal symptoms and jaundice in six months after hospitalization
Key exclusion criteria
Patients who refuse participating in research in response to opt-out notification
Patients with malignant tumors requiring treatment currently
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Yamada |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10 Konandai, Konan-ku, Yokohama
TEL
0458321111
hyyoh16y@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Yamada |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10 Konandai, Konan-ku, Yokohama
TEL
0458321111
Homepage URL
https://www.nanbu.saiseikai.or.jp/media/tounai2019D31.pdf
hyyoh16y@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
yamada taku
Funding Source
Organization
Saiseikai Yokohamashi Nanbu Hospital
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
Saiseikai Yokohamashi Nanbu Hospital
Address
3-2-10 Konandai, Konan-ku, Yokohama
Tel
0458321111
hyyoh16y@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
| 2023 | Year | 01 | Month | 07 | 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
1060
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
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study, with no intervention.
Management information
Registered date
| 2023 | Year | 01 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056896
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
