UMIN-CTR Clinical Trial

Basic information
Public title	Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Acronym	Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Scientific Title	Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Scientific Title:Acronym	Development of plasma ghrelin level as a novel marker for risk stratification of gastric cancer
Region	Japan

Condition
Condition	H. pylori-infected gastritis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this pilot study is to evaluate the diagnostic utility of plasma ghrelin levels to predict the severity of gastric mucosal atrophy after H. pylori eradication better than serum pepsinogen levels.
Basic objectives2	Others
Basic objectives -Others	evaluation of a novel risk stratification marker
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of plasma ghrelin levels during the H. pylori eradication therapy
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	Patients who visit Keio University Hospital for H. pylori eradication therapy. They are planning to undergo esophagogastroduodenoscopy.
Key exclusion criteria	Patients after a laparotomy for the resection of esophagus or stomach
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hidekazu Middle name Last name Suzuki
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL	03-5363-3914
Email	hsuzuki@a6.keio.jp

Public contact
Name of contact person	1st name Juntaro Middle name Last name Matsuzaki
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL	03-5363-3914
Homepage URL
Email	juntaro.matsuzaki@gmail.com

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Tosoh Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	2014 Year 07 Month 08 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000016859
Publication of results	Published

Result
URL related to results and publications	https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000016859
Number of participants that the trial has enrolled	27
Results	Total and acyl plasma ghrelin levels demonstrated no significant change from before treatment to 48 weeks after eradication; however, there was a significant difference between open-type and closed-type atrophic gastritis. The PG I/II ratio increased significantly from 48 weeks after H. pylori eradication. The severity of the histological intestinal metaplasia scores correlated inversely with plasma total ghrelin levels from before to 48 weeks after H. pylori eradication.
Results date posted	2022 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The severity of atrophic gastritis is significantly associated with the risk of gastric cancer. Although the current gold standard for assessing the gastric cancer risk is esophagogastroduodenoscopy with a pathological examination, the development of less-invasive biomarkers is warranted for efficient risk stratification of gastric cancer. Serum pepsinogens (PGs) are biomarkers used to predict the extent of gastric mucosal atrophy; however, they are not an accurate reflection of gastric mucosal atrophy after Helicobacter pylori eradication. The present study was conducted to investigate the usefulness of plasma ghrelin levels as a marker for gastric mucosal atrophy, and as a risk stratification marker for gastric cancer, even after H. pylori eradication.
Participant flow	Patients who received H. pylori eradication treatment were enrolled in the study. The severity of gastric mucosal atrophy was evaluated both endoscopically and histologically. Serum pepsinogen and plasma ghrelin levels were measured before and at 1, 12, 24, and 48 weeks after treatment. The study was approved by the Research Ethics Committee of the Keio University School of Medicine (no. 20140102; July 8, 2014).
Adverse events	None
Outcome measures	The severity of gastric mucosal atrophy was evaluated both endoscopically and histologically. Serum pepsinogen and plasma ghrelin levels were measured before and at 1, 12, 24, and 48 weeks after treatment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 05 Day
Date of IRB	2014 Year 07 Month 03 Day
Anticipated trial start date	2015 Year 01 Month 26 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, we will observe the following items before and after H. pylori eradication therapy. 1. Blood exam including plasma ghrelin levels, serum pepsinogen levels (before eradication/ 1 week, 3 months, 6 months, 1 year after eradication) 2. Esophagogastroduodenoscopy (before eradication, 1 year after eradication)

Management information
Registered date	2014 Year 07 Month 07 Day
Last modified on	2022 Year 01 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016859