UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041292
Receipt number R000047123
Scientific Title Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers
Date of disclosure of the study information 2020/08/03
Last modified on 2020/08/03 17:03:43

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Basic information

Public title

Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers

Acronym

Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers

Scientific Title

Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers

Scientific Title:Acronym

Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to assess the utility of S100 protein levels in the duodenal juice collected by oral endoscopy without pancreatic duct cannulation to detect pancreatic cancers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The S100 protein concentration in the duodenal juice to detect patients with pancreatic cancers

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

At the beginning of the endoscopy, the duodenum is entered within a few minutes and we collect the duodenal juice. The duodenal juice is collected within 3 minutes. The sample is diluted and stored at -80degrees.

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Pancreatic cancer patients
1) Aged 50 or more
2) Patients who undergo preoperative screening upper gastrointestinal endoscopy or endoscopic ultrasonography (EUS) for the assessment of pancreatic cancer
3) Written informed consent
4) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer
5) Patients who have undergone no surgery in gastrointestinal lesion
6) Patients without malignant disease in bile duct

The patients who undergo physical examination
1) Aged 50 or more.
2) Patients proven to have normal pancreas by EUS
3) Patients who undergo screening upper gastrointestinal endoscopy for their pancreatic diseases
4) Written informed consent
5) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer
6) Patients who have undergone no surgery in gastrointestinal lesion, such as gastrectomy, pancreatoduodenectomy and so on.
7) Patients without malignant disease in bile duct

Key exclusion criteria

1) They have no drug hypersensitivity.
2) The doctor-in-charge figures them to be suitable for this study.

Target sample size

65


Research contact person

Name of lead principal investigator

1st name Nakamura
Middle name
Last name Masafumi

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Oncology

Zip code

8128582

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-631-2920

Email

mnaka@surg1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Ideno
Middle name
Last name Noboru

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Oncology

Zip code

8128582

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-642-5444

Homepage URL


Email

ideno@surg1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University certified institutional review board for clinical trials

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

Tel

0926425774

Email

bynintei@jimu.kyushu-u.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 08 Month 03 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

65

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

No longer recruiting

Date of protocol fixation

2020 Year 07 Month 15 Day

Date of IRB

2020 Year 07 Month 15 Day

Anticipated trial start date

2020 Year 07 Month 15 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 03 Day

Last modified on

2020 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047123


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name