UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047326 |
|---|---|
| Receipt number | R000053977 |
| Scientific Title | A minimally invasive test for diagnosis of pancreatic and biliary tract neoplasm using cell-free nucleic acid and residual specimens |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/04/03 16:41:18 |
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Basic information
Public title
Precision medicine for diagnosis of pancreatic and biliary
tract neoplasm using cell-free nucleic acid and residual specimens
Acronym
A minimally invasive test for diagnosis of pancreatic and
biliary tract neoplasm
Scientific Title
A minimally invasive test for diagnosis of pancreatic and
biliary tract neoplasm using cell-free nucleic acid and
residual specimens
Scientific Title:Acronym
A minimally invasive test for diagnosis of pancreatic and
biliary tract neoplasm
Region
| Japan |
Condition
Condition
Patients with pancreatic and biliary tract neoplasm and
their precancerous lesions, and individuals at high risk of
developing pancreatic and biliary tract cancers, and
patients with benign gastrointestinal disorders including
cholelithiasis and gastroduodenal ulcer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the efficacy and feasibility of the quantitative
detection of tumor-associated nucleic acid in the body
fluid, including blood, pancreatic and bile juice, duodenum
fluid, and residual tissue specimens for diagnosis of
pancreatic and biliary tract neoplasm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic value of quantitative detection and monitoring
of tumor-associated alterations in body fluid cell-free
nucleic acid and tissue-derived nucleic acid in pancreatic
and biliary tract neoplasm.
Key secondary outcomes
Surveillance of individuals at high risk of developing
pancreatic and biliary tract neoplasm by quantitative
detection and monitoring of tumor-associated alterations
in cell-free nucleic acid and tissue-derived nucleic acid.
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
･Patients with pancreatic and biliary tract neoplasm
including benign/pre-cancerous lesions, individuals at
high risk of developing these tumors diagnosed at
Asahikawa Medical University Hospital and affiliated/
collaborating hospitals.
･Patients aged 20 years or older at the time of diagnosis,
regardless of gender
･Patients with a benign digestive disorder such as gall
stone and gastroduodenal ulcer.
･Patients with written informed consent.
Key exclusion criteria
･Patients with severe heart disease
･Patients with severe renal disease
･Patients with serious mental illness
･Patients complicated with severe infection
･Patients with severe diabetes
･Patients with severe dehydration and malnutrition
･Patients who have other serious complications and are
considered difficult to participate
･Patient who judged inappropriate by an attendant
physician
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Mizukami |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Medicine
Zip code
078-8510
Address
2-1 Midorigaoka Higashi, Asahikawa, Hokkaido 078-8510
TEL
0166-68-2462
mizu@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Mizukami |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Medicine
Zip code
078-8510
Address
2-1 Midorigaoka Higashi, Asahikawa, Hokkaido 078-8510
TEL
0166-68-2462
Homepage URL
mizu@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Hitachi High-Tech Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa-Kosei General Hospital
Japanese Red Cross Asahikawa Hospital
Asahikawa City Hospital
Teine Keijinkai Hospital
Sapporo Higashi Tokushukai Hospital
Nayoro City Hospital
Engaru-Kosei General Hospital
Shibetsu City Hospital
Name of secondary funder(s)
Hitachi High-Tech Corporation
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
旭川医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053977
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
