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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040962
Receipt No. R000046693
Scientific Title Prospective study on association between endoscopic hematin findings and gastric acidity
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/01

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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