UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038466
Receipt number R000042563
Scientific Title The relationship between serum pepsinogen levels and gastric atrophy
Date of disclosure of the study information 2019/11/02
Last modified on 2020/10/14 16:04:55

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Basic information

Public title

The relationship between serum pepsinogen levels of and gastric atrophy

Acronym

The relationship between serum pepsinogen levels and gastric atrophy

Scientific Title

The relationship between serum pepsinogen levels and gastric atrophy

Scientific Title:Acronym

The relationship between serum pepsinogen levels and gastric atrophy

Region

Japan


Condition

Condition

gastritis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the relationship between serum pepsinogen levels and gastritis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The relationship between serum pepsinogen levels and 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Esophagoduodenoscopy. Serum pepsinogen.

Key exclusion criteria

no

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Takahisa
Middle name
Last name Furuta

Organization

Hamamatsu University School of Medicine

Division name

Center for clinical research

Zip code

4300906

Address

Handayama 1-20-1, Higashi ku, Hamamatsu shi, Shizuoka ken

TEL

0534352111

Email

takahr99@hama-med.ac.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Suzuki

Organization

Hamamatsu Univesity School of Medicine

Division name

First department of Medicine

Zip code

4300906

Address

Handayama 1-20-1, Higashi ku, Hamamatsu shi, Shizuoka ken

TEL

0534352111

Homepage URL


Email

takahr99@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Hamamatsu , Shizuoka

Tel

0534352111

Email

takahr99@hama-med.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

2019 Year 11 Month 02 Day


Related information

URL releasing protocol

h

Publication of results

Unpublished


Result

URL related to results and publications

h

Number of participants that the trial has enrolled

1207

Results

PG I: A0 44.1, A1 40.6 and A2 28.4.

Results date posted

2020 Year 10 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who were eradicated of H. pylori.

Participant flow

opt out

Adverse events

no

Outcome measures

The levels of PG I and PG II.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 07 Month 11 Day

Date of IRB

2019 Year 09 Month 02 Day

Anticipated trial start date

2019 Year 09 Month 02 Day

Last follow-up date

2019 Year 09 Month 02 Day

Date of closure to data entry

2019 Year 09 Month 02 Day

Date trial data considered complete

2019 Year 09 Month 02 Day

Date analysis concluded

2019 Year 12 Month 01 Day


Other

Other related information

Retrospective observational study


Management information

Registered date

2019 Year 11 Month 01 Day

Last modified on

2020 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name