UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022063 |
|---|---|
| Receipt number | R000025432 |
| Scientific Title | A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2025/05/07 08:45:24 |
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Basic information
Public title
A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Acronym
Serum miRNA panel in the diagnosis of pancreatobiliary cancer
Scientific Title
A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Scientific Title:Acronym
Serum miRNA panel in the diagnosis of pancreatobiliary cancer
Region
| Japan |
Condition
Condition
Pancreatobiliary cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the diagnostic value of serum microRNA panel versus CA19-9 in pancreatic and biliary tract cancer, prospectively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1. In discriminating pancreatobiliary cancer from healthy control, non-inferiority of specificity of serum miRNA panel when comparing the reported CA19-9 data (90-95%) and superiority of sensitivity of serum miRNA panel when comparing CA19-9
2. In discriminating pancreatobiliary cancer from inflammatory pancreatobiliary disease, non-inferiority of sensitivity of serum miRNA panel when comparing the reported CA19-9 data (70-80%) and superiority of specificity of serum miRNA panel when comparing CA19-9
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healty subjects, patients with inflammatory pancreatobiliary disease, or patients with pancreatobiliary cancer or gastrointestinal cancer
Key exclusion criteria
patients with inflammatory pancreatobiliary disease and malignant disease, patients with anti-cancer treatment for cancer
Target sample size
1280
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Mitsunaga |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Chiba
TEL
+81-7133-1111
mokojima@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Mitsunaga |
Organization
National Cancer Center Hospital East
Division name
Deparment of Hepatobiliary and Pancreatic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Chiba
TEL
+81-7133-1111
Homepage URL
smitsuna@east.ncc.go.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-kuTokyo, 104-0045 Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39838364/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39838364/
Number of participants that the trial has enrolled
1487
Results
Index-1, a combination of five serum miRNAs (hsa-miR-1343-5p, hsa-miR-4632-5p, hsa-miR-4665-5p, hsa-miR-665, and hsa-miR-6803-5p) showed a sensitivity and specificity of > 80% and an AUC outperforming that of CA19-9 in the exploratory, validation, and independent validation sets. The AUC of Index-1 was superior to that of CA19-9 (0.856 vs. 0.649, p = 0.038) for detecting T1 tumors. miR-665, a component of Index-1, was expressed in human pancreatic cancer cells, and its transfection inhibited cell growth.
Results date posted
| 2025 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 21 | Day |
Baseline Characteristics
Patients were divided into the exploratory set (150 healthy and 134 PBca), the validation (50 healthy, 47 PBca) or the independent validation (50 healthy, 46 PBca) set.
Participant flow
A total of 1428 participants were enrolled in the study between June 2016 and April 2021 at 12 institutions in Japan and assigned to the exploratory set with stepwise serum processing (n = 827), the validation set (n = 97), or the independent validation set (n = 113). Consequently, we divided the participants with optimized serum processing into an exploratory set (n = 284), a validation set (n = 97), and an independent validation set (n = 96).
Adverse events
None
Outcome measures
The cutoff values for the c-miRNA signature and CA19-9 levels were set at 0 and 37 U/mL, respectively. Any miRNA signature that exceeded 80% sensitivity and 80% specificity and with a 95% CI for the AUC exceeding that of CA19-9 in the exploratory set was further evaluated in the validation and independent validation sets in the same way as that in the exploratory set.
Plan to share IPD
Requests for data and samples should be made to the corresponding author, Shuichi Mitsunaga, via email. Data and samples will be made available upon the approval of reasonable requests to the lead author (Shuichi Mitsunaga) and Toray Industries, Inc.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 06 | Month | 19 | Day |
Other
Other related information
Trial registration was resumed in 2018.
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025432
