UMIN-CTR Clinical Trial

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

Early gastric cancer/gastric adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Published

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

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 related information

No special instruction

Registered date

2016

Year

04

Month

10

Day

Last modified on

2018

Year

09

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025203