UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040999
Receipt number R000046814
Scientific Title Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/04 13:28:50

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Basic information

Public title

Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)

Acronym

Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)

Scientific Title

Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)

Scientific Title:Acronym

Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)

Region

Japan


Condition

Condition

Esophagogastroduodenoscopy for screening purposes

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examining endoscopic findings based on Kyoto classification of gastritis from the viewpoint of gastric acid environment, and clarifying endoscopic findings useful for evaluation of strong acidic condition

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Predictability for strong acidic condition of endoscopic findings based on Kyoto classification of gastritis

Key secondary outcomes



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

1. Planning to undergo esophagogastroduodenoscopy for screening purposes at our hospital.
2. ECOG-Performance Status is 0 or 1.
3. The age at the time of registration is 20 years or older.
4. Written informed consent to participate in the study is obtained.

Key exclusion criteria

1. Patients who started or stopped taking antacid within the last 7 days including the date of endoscopy.
2. Patients with serious underlying disease (cirrhosis/end stage renal failure).
3. Patients with a history of gastrectomy.
4. Patients with psychiatric disorders or symptoms who may have difficulty participating in the study.
5. In addition, patients who are considered unsuitable for conducting this study by the investigator.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Katsuta

Organization

Oita Red Cross Hospital

Division name

Department of Gastroenterology

Zip code

870-0033

Address

3-2-27, Chiyo-Machi, Oita-shi, Oita, Japan

TEL

097-532-6181

Email

katsuta@oita-u.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Katsuta

Organization

Oita Red Cross Hospital

Division name

Department of Gastroenterology

Zip code

870-0033

Address

3-2-27, Chiyo-Machi, Oita-shi, Oita, Japan

TEL

097-532-6181

Homepage URL


Email

katsuta@oita-u.ac.jp


Sponsor or person

Institute

Oita Red Cross Hospital

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

Oita Red Cross Hospital

Address

3-2-27, Chiyo-Machi, Oita-shi, Oita, Japan

Tel

097-532-6181

Email

soumukikaku@oita-rc-hp.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 07 Month 06 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

Preinitiation

Date of protocol fixation

2020 Year 06 Month 07 Day

Date of IRB

2020 Year 06 Month 09 Day

Anticipated trial start date

2020 Year 07 Month 06 Day

Last follow-up date

2020 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We observe in the stomach using an esophagogastroduodenoscope and check the presence of 19 findings based on Kyoto classification of gastritis and pH of fasting gastric juice.


Management information

Registered date

2020 Year 07 Month 04 Day

Last modified on

2020 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046814


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name