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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021857
Receipt No. R000025203
Scientific Title Chemoprevention of gastric cancer by H. pylori eradication or taking aspirin: analysis of molecular alterations
Date of disclosure of the study information 2016/04/10
Last modified on 2018/09/26

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Basic information
Public title Chemoprevention of gastric cancer by H. pylori eradication or taking aspirin: analysis of molecular alterations
Acronym H. pylori eradication or taking aspirin and chemoprevention of gastric cancer
Scientific Title Chemoprevention of gastric cancer by H. pylori eradication or taking aspirin: analysis of molecular alterations
Scientific Title:Acronym H. pylori eradication or taking aspirin and chemoprevention of gastric cancer
Region
Japan

Condition
Condition Early gastric cancer/gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clarify the molecular alterations in intestinal metaplasia (IM) or gastric atrophy (GA) in patients who underwent endoscopic resection of early gastric cancer or adenoma after 3 years or more of H. pylori treatment or taking a daily aspirin.
Basic objectives2 Others
Basic objectives -Others To explore the biomarkers related to gastric carcinogenesis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare of molecular alterations related to carcinogenesis in IM or GA among H. pylori infected gastritis patients and patients with and without cancer after 3 years or more of H. pylori treatment or taking a daily aspirin.
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 (1) Patients who underwent endoscopic resection of early gastric cancer or adenoma after 3 years or more of H. pylori treatment or taking a daily aspirin.
(2) Chronic gastritis patients after 3 years or more of H. pylori treatment or taking a daily aspirin.
(3) H. pylori associated chronic gastritis patients.
Key exclusion criteria (1)Patients with malignancy in other organs.
(2)Patients with having a past history of esophagectomy or gastrectomy.
(3)Patients who have determined by
the physicians to have any reasons of unqualified.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gasstroenterology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6662
Email watarij@hyo-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gasstroenterology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6662
Homepage URL
Email watarij@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine,
Division of Gasstroenterology,
Department of Internal Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
Address
Tel
Email

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
2016 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29042646
Number of participants that the trial has enrolled
Results
In these studies, we evaluated the effects of H. pylori eradication and aspirin on
genetic/epigenetic alterations in precancerous conditions, i.e., atrophic mucosa (AM) and intestinal metaplasia (IM), in patients with and without gastric cancer. DNA was extracted from goblet IM and AM separately using the laser capture microdissection. 
1. H. pylori eradication was associated with significant reductions of methylation of several genes/loci in AM, but not in IM. In
contrast, the incidence of CpG island methylator phenotype (CIMP) in IM was significantly higher in patients with gastric cancer than in those without. miR-124a-3 methylation and miR-34c methylation were more frequently identified in IM, with very few in AM.(Conclusions) H. pylori eradication can reverse methylation only AM. CIMP in IM may have potential as a surrogate maker of GC development, and methylation of miR-124a-3 and miR-34c is a molecular event in IM that may not be associated with GC development.

2. Aspirin use was associated with a significant reduction of CDH1 methylation in AM, but was less effective in reversing the methylation that occurred in IM. Frequent
hypermethylation including that of CDH1 in AM increased in patients with gastric cancer compared to those without, and CDH1 methylation was an independent predictive marke of gastric cancer. 
(Conclusions) In patients with long-term aspirin use, the changes of molecular events in AM but not IM may be an important factor in the reduction of cancer incidence. In addition, methylation of the CDH1 gene in AM may be a surrogate of gastric cancer.
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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No special instruction

Management information
Registered date
2016 Year 04 Month 10 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025203

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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