UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection in patients without previous eradication therapy.
Title of the study (Brief title)	Comparison of the diagnostic tests for the diagnosis of Helicobacter pylori infection.
Region	Japan

Condition
Condition	Patients with suspicious infection of Helicobacter pylori.
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy of the diagnostic tests for Helicobacter pylori infection in patient without previous eradication therapy with special reference to false negative rates of a rapid urease test in patients taking a proton pump inhibitor.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	False negative rates of a rapid urease test in patients taking a proton pump inhibitor.
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	Diagnosis
Type of intervention	Maneuver Other
Interventions/Control_1	Endoscopic biopsy, rapid urease test, urea breath test, and blood sampling.
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	Patients with suspicious infection of Helicobacter pylori.
Key exclusion criteria	The exclusion criteria included previous eradication therapy and any contraindication for esophagogastroduodenoscopy.
Target sample size	100

Research contact person
Name of lead principal investigator	Kenji Tominaga.
Organization	Toho University Ohashi Medical Center.
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine.
Address	2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.
TEL	03-3468-1251
Email	kenjitominaga@hotmail.com

Public contact
Name of contact person	Kenji Tominaga.
Organization	Toho University Ohashi Medical Center.
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine.
Address	2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.
TEL	03-3468-1251
Homepage URL
Email	kenjitominaga@hotmail.com

Sponsor
Institute	Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center.
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東邦大学医療センター大橋病院(東京都)

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 20 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 25 Day
Last modified on	2017 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015152