UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046730 |
|---|---|
| Receipt number | R000053124 |
| Scientific Title | MicroRNA Markers in Bile for the Diagnosis of Pancreatic and Biliary-Tract Cancers |
| Date of disclosure of the study information | 2022/01/26 |
| Last modified on | 2023/01/25 15:29:27 |
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Basic information
Public title
MicroRNA Markers in Bile for the Diagnosis of Pancreatic and Biliary-Tract Cancers
Acronym
MicroRNA Markers in Bile for the Diagnosis of Pancreatic and Biliary-Tract Cancers
Scientific Title
MicroRNA Markers in Bile for the Diagnosis of Pancreatic and Biliary-Tract Cancers
Scientific Title:Acronym
MicroRNA Markers in Bile for the Diagnosis of Pancreatic and Biliary-Tract Cancers
Region
| Japan |
Condition
Condition
pancreatic cancer and biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the role of cancer-specific microRNAs in the detection of pancreatic and biliary tract cancer from Bile.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to assess the utility of select miRNAs as diagnostic markers for differentiating PC from BTC and from individuals without PC and BTC by comparing the differential expression of miRNAs in bile among individuals with PC, BTC and benign biliary obstruction.
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
The study population consisting of patients with PC, BTC, benign biliary obstruction who underwent ERCP or PTBD for the purpose of biliary drainage, and pathologically confirmed of bile at the Department of Gastroenterology and Hepatology, Nihon University School of Medicine between April 2019 and May 2023. From this population, we selected patients having available surplus storage bile and serum.All patients signed an informed consent form for research prior to biliary drainage or blood sampling being performed.
Key exclusion criteria
Patients with prior chemotherapy due to PC and BTC or cancers of other organs were excluded from the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Imazu |
Organization
Nihon University Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
101-8309
Address
1-6 kandasurugadai, chiyoda-ku, Tokyo, 101-8309, Japan
TEL
03-3293-1711
imazu.hiroo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kuniyoshi |
Organization
Nihon University Itabashi Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
1738610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan
TEL
03-3972-8111
Homepage URL
kuniyoshi.noriyuki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University Itabashi 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
Department of Medicine, Nihon University School of Medicine
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan
Tel
03-3972-8111
med.rinsyokenkyu@nihon-u.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
| 2022 | Year | 01 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
h
Management information
Registered date
| 2022 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053124
