UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044036 |
|---|---|
| Receipt number | R000050283 |
| Scientific Title | The diagnosis of a pancreatic or biliary tract lesion with cell-free DNA in pancreatic juice or bile |
| Date of disclosure of the study information | 2021/04/26 |
| Last modified on | 2023/04/28 19:48:49 |
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Basic information
Public title
The diagnosis of a pancreatic or biliary tract lesion with cell-free DNA in pancreatic juice or bile
Acronym
Diagnosis of a pancreatic or biliary tract lesion with cell-free DNA
Scientific Title
The diagnosis of a pancreatic or biliary tract lesion with cell-free DNA in pancreatic juice or bile
Scientific Title:Acronym
Diagnosis of a pancreatic or biliary tract lesion with cell-free DNA
Region
| Japan |
Condition
Condition
Pancreaticobiliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the efficacy of cfDNA analysis in pancreatic juice and bile for the diagnosis of pancreaticobiliary lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity, specificity and accuracy of cfDNA analysis for malignancy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with pancreatic or bile duct stricture who require ERCP-related procedures
(2) Patients who provided informed consent
Key exclusion criteria
(1) Patients in which appropriate samples are not obtained
(2) Patients who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-176-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University 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
Hokkaido University Hospital Institutional Review Board
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-716-1161
crjimu@huhp.hokuda.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
| 2021 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gene mutations of cfDNA in pancreatic juice or bile, progression of lesions in images, changes in serum tumor markers, gene mutations in surgical or biopsy specimens, clinical course
Management information
Registered date
| 2021 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050283
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
