UMIN-CTR Clinical Trial

Basic information
Public title	Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis
Acronym	Research of biomarker for pancreatic or bile duct cancers
Scientific Title	Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis
Scientific Title:Acronym	Research of biomarker for pancreatic or bile duct cancers
Region	Japan

Condition
Condition	pancreatic cancer, bile duct cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Research of biomarkers for pancreatic or bile duct cancers using peptide analysis.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peptide analysis using BLOTCHIP
Key secondary outcomes	1 Pathological diagnosis 2 Imaging diagnosis 3 Clinical stage

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	All patients diagnosed as pancreatic or bile duct cancers at Toyama University Hospital with written informed consent.
Key exclusion criteria	1 Patients with high risk of complications from blood sampling. 2 Patients who do not or can not give informed consent.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takahara Middle name Last name Terumi
Organization	University of Toyama
Division name	Department of Advanced Technology for Gastroenterological Cancer Therapy
Zip code	930-0194
Address	2630 sugitani, Toyama city, Toyama, Japan
TEL	076-434-7440
Email	taka@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Tajiri Middle name Last name Kazuto
Organization	University of Toyama
Division name	Third Department of Inetrnal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama, Japan
TEL	076-431-7301
Homepage URL
Email	tajikazu@med.u-toyama.ac.jp

Sponsor
Institute	Universtiy of Toyama
Institute
Department

Funding Source
Organization	Self funding
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	Ethics Committee, University of Toyama
Address	2630 sugitani, Toyama city, Toyama, Japan
Tel	076-415-8857
Email	rinri@adm.u-toyama.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	2020 Year 05 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	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 04 Month 07 Day
Anticipated trial start date	2020 Year 05 Month 07 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis

Management information
Registered date	2020 Year 04 Month 30 Day
Last modified on	2020 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045847