UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040276
Receipt number R000045847
Scientific Title Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/30 10:32:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Universtiy of Toyama

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045847


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name