UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on association between endoscopic hematin findings and gastric acidity
Acronym	Prospective study on association between endoscopic hematin findings and gastric acidity
Scientific Title	Prospective study on association between endoscopic hematin findings and gastric acidity
Scientific Title:Acronym	Prospective study on association between endoscopic hematin findings and gastric acidity
Region	Japan

Condition
Condition	Screening upper endoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether endoscopically visualized hematin can be a finding indicating a strong acid environment in the stomach
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between the presence of hematin and fasting gastric juice pH
Key secondary outcomes	The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of endoscopic hematin for predicting strong acidity

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. Patients who will underwent upper gastrointestinal screening endoscopy 2. ECOG-performance Status is 0 or 1. 3. The age at registration is 20 years or older. 4. Written informed consent from the patient to participate in the study.
Key exclusion criteria	1. Patients who started or stopped taking antacid within the last 7 days including the date of endoscopic examination. 2. Patients with serious underlying diseases (cirrhosis/end stage renal failure) 3. Patients with a history of gastrectomy 4. 4. Patients with mental illness or symptoms who may have difficulty participating in the study. 5. Other patients who are deemed inappropriate for the trial responsible physician or the test sharing doctor to conduct this study
Target sample size	325

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Ueo
Organization	Oita Red Cross Hospital
Division name	Gastroenterology
Zip code	870-0033
Address	Chiyo-machi, Oita
TEL	0975326181
Email	ueo14@athena.ocn.ne.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Ueo
Organization	Oita Red Cross Hospital
Division name	Gastroenterology
Zip code	870-0033
Address	Chiyo-machi, Oita
TEL	0975326181
Homepage URL
Email	ueo14@athena.ocn.ne.jp

Sponsor
Institute	Oita Red Cross Hospital
Institute
Department

Funding Source
Organization	Oita Red Cross Hospital
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 of Oita Red Cross Hospital
Address	Chiyo-machi, Oita
Tel	0975326181
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
Anticipated trial start date	2020 Year 07 Month 06 Day
Last follow-up date	2020 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A cross-sectional study to prospectively evaluate hematin and fasting gastric juice pH

Management information
Registered date	2020 Year 07 Month 01 Day
Last modified on	2020 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046693