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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00197470
Other study ID # Mitsu-001
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated September 12, 2005
Start date January 2000

Study information

Verified date September 2005
Source Hamamatsu University
Contact Mitsushige Sugimoto
Phone +81-53-435-2261
Email mitsu@hama-med.ac.jp
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. We intended to clarify the association between polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.


Description:

H. pylori infection has close associations with the development of peptic ulcer diseases as well as gastric cancer, gastric adenoma, and gastric MALT lymphoma. The association of the host genetics with the susceptibility to various gastroduodenal disorders has been intensively investigated in the pathogenesis of peptic ulcer and gastric cancer by H. pylori infection .

In chronic active gastritis induced by H. pylori infection, activated neutrophils and mononuclear cells produce several pro-inflammatory and anti-inflammatory cytokines. In fact, levels of pro-inflammatory and anti-inflammatory cytokines are elevated in gastric mucosa infected with H. pylori.

Cytokine polymorphisms are associated with various inflammatory and autoimmune diseases. Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. However, the roles of the IL-10 polymorphisms on the pathogenesis of H. pylori-related gastric cancer and peptic ulcer have not been fully elucidated.It is unclear whether pro-inflammatory and anti-inflammatory cytokines polymorphisms were associated with pathogenesis of peptic ulcer and gastric cancer in Japan. Then, we intended to clarify the association between polymorphisms of IL-10 and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Exclusion Criteria:

- patinets without H. pylori

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
IL-1, TNF-alpha, Il-10


Locations

Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu

Sponsors (2)

Lead Sponsor Collaborator
Hamamatsu University Yokoyama Foundation for Clinical Pharmacology

Country where clinical trial is conducted

Japan, 

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