UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000015871
Receipt number	R000018201
Scientific Title	The development of new diagnostic marker for pancreatic cancer by use of endoscopic ultrasound-guided fine needle aspiration
Date of disclosure of the study information	2014/12/10
Last modified on	2017/06/11 19:21:02

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Basic information

Public title

The development of new diagnostic marker for pancreatic cancer by use of endoscopic ultrasound-guided fine needle aspiration

Acronym

The development of new diagnostic marker for pancreatic cancer by use of EUS-FNA.

Scientific Title

The development of new diagnostic marker for pancreatic cancer by use of endoscopic ultrasound-guided fine needle aspiration

Scientific Title:Acronym

The development of new diagnostic marker for pancreatic cancer by use of EUS-FNA.

Region

Japan

Condition

Pancreatic Cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The protein markers(VEGF-A, Flk-1) of pancreatic cancer are measured during EUS-FNA, and compared with those of surgical specimen.
In addition, S100P protein which is specific pancreatic cancer protein marker, is measured in a parallel way.
If those markers could be measured, pre-operative prognosis, or therapeutic selectivity of molecular target drug might be obtained.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

i)VEGF-A and Flk-1 expression which obtained from EUS-FNA's specimen and those of surgical specimen, will be copared with each other.
ii)To develop a new biomarker for pancreatic cancer diagnosis, the S100P expression is measured.

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Pancreas cancer.

Interventions/Control_2

Benign oancreatic lesion.

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 who had susppected pancreatic cancer, from the examinations of computed tomography or abdominal ultrasonography.
2. Performance status; 0,1,2
3. Over 20 years of age.
4. Patients who had informed consent

Key exclusion criteria

1. Patients who receive anticoagulant drug or antiplatelet drug.
2. Patients affected with acute pancreatitis.
3. Patients undergone already chemotherapy or radiation therapy.
4. Women during pregnancy and of childbearing potential, or presently breastfeeding.
5. Patients who are affected with psychiatric disorder, and can not be enrolled in this clinical trial, due to loss of judgment.
6. Patients who are ruled unfit to enroll this crinical trial, in the judgment of endoscopists or attending doctors.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Masafumi Chiba

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

Address

3-19-18 nishishinbashi minato ward, tokyo, japan

TEL

03-3433-1111(3181)

Email

ccl09720@yahoo.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Hiroo Imazu

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

Address

3-19-18 nishishinbashi minato ward, tokyo, japan

TEL

03-3433-1111

Homepage URL

Email

himazu21@hotmail.co.jp

Sponsor or person

Institute

Department of Endoscopy, The Jikei University School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Department of Endoscopy, The Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 10 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

https://www.spandidos-publications.com/or/37/4/1943

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

Completed

Date of protocol fixation

2014 Year 09 Month 08 Day

Date of IRB

Anticipated trial start date

2014 Year 12 Month 14 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2014 Year 12 Month 08 Day

Last modified on

2017 Year 06 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018201

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name