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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028284
Receipt No. R000032379
Scientific Title A minimally invasive test for diagnosis of pancreatic neoplasm using cell-free nucleic acid
Date of disclosure of the study information 2017/07/19
Last modified on 2019/07/29

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Basic information
Public title A minimally invasive test for
diagnosis of pancreatic neoplasm
using cell-free nucleic acid
Acronym Liquid biopsy for pancreatic neoplasm
Scientific Title A minimally invasive test for
diagnosis of pancreatic neoplasm
using cell-free nucleic acid
Scientific Title:Acronym Liquid biopsy for pancreatic neoplasm
Region
Japan

Condition
Condition Patients with pancreatic cancer and
its precancerous lesions, and
individuals at high risk of developing
pancreatic neoplasm, and patients
with benign gastrointestinal
disorders such as cholelithiasis and
gastroduodenal ulcer
Classification by specialty
Hepato-biliary-pancreatic medicine Gastrointestinal surgery
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
and pancreatic juice samples
collected from the duodenum for
diagnosis of pancreatic 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
cell-free nucleic acid for the
diagnosis of pancreatic neoplasm.
Key secondary outcomes Surveillance of individuals at high
risk of developing pancreatic
neoplasm by quantitative detection
and monitoring of tumor-associated
alterations in cell-free 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 malignant pancreatic tumor
and benign/pre-cancerous lesions.
・Individuals at high risk of developing
pancreatic neoplasm.
・Patients with benign digestive disorder
who receive upper endoscopic examination.
・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 350

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Mizukami
Organization Asahikawa Medical University
Division name Department of Medicine (Division of Gastroenterology and Hematology/Oncology)
Zip code 0788510
Address 2-1 Midorigaoka Higashi, Asahikawa,Hokkaido 078-8510
TEL 0166-68-2462
Email 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 Department of Medicine (Division of Gastroenterology and Hematology/Oncology)
Zip code 0788510
Address 2-1 Midorigaoka Higashi, Asahikawa,Hokkaido 078-8510
TEL 0166-68-2462
Homepage URL
Email mizu@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Hitachi High-Technologies Corporation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Sapporo Higashi Tokushukai Hospital
Asahikawa-Kosei General Hospital
Japanese Red Cross Asahikawa Hospital
Shibetsu City Hospital
Teine Keijinkai Hospital
Name of secondary funder(s) Hitachi High-Technologies Corporation

IRB Contact (For public release)
Organization N/A
Address N/A
Tel N/A
Email 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
2017 Year 07 Month 19 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
2017 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 07 Month 19 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032379

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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