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Cytokine Gene Polymorphisms in Gastric Diseases

Primary Purpose

Gastric Ulcer, Duodenal Ulcer, Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

IL-1, TNF-alpha, Il-10

About this trial

This is an interventional diagnostic trial for Gastric Ulcer

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Exclusion Criteria: patinets without H. pylori

Sites / Locations

Hamamatsu University School of MedicineRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00197470

First Posted

September 12, 2005

Last Updated

September 12, 2005

Sponsor

Hamamatsu University

Collaborators

Yokoyama Foundation for Clinical Pharmacology

1. Study Identification

Unique Protocol Identification Number

NCT00197470

Brief Title

Cytokine Gene Polymorphisms in Gastric Diseases

Official Title

Effects of Pro-Inflammatory and Anti-Inflammatory Cytokine Gene Polymorphism on the Development of Gastric Cancer and Peptic Ulcer in Japanese

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hamamatsu University

Collaborators

Yokoyama Foundation for Clinical Pharmacology

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Ulcer, Duodenal Ulcer, Gastric Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

IL-1, TNF-alpha, Il-10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Exclusion Criteria: patinets without H. pylori

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mitsushige Sugimoto

Phone

+81-53-435-2261

mitsu@hama-med.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MItsushige Sugimoto

Organizational Affiliation

First department of medicine, Hamamatsu University School of medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Hamamatsu University School of Medicine

City

Hamamatsu

ZIP/Postal Code

431-3192

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mitsushige Sugimoto

Phone

+81-53-435-2261

mitsu@hama-med.ac.jp

12. IPD Sharing Statement

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Cytokine Gene Polymorphisms in Gastric Diseases

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