Gastric UlcerNCT00197470
Cytokine Gene Polymorphisms in Gastric Diseases
A study testing IL-1, TNF-alpha, Il-10 in people with Gastric Ulcer and Duodenal Ulcer, run by Hamamatsu University at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Gastric Ulcer, Duodenal Ulcer, Gastric Cancer
- What is being tested?
- IL-1, TNF-alpha, Il-10
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Jan 2000to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- patinets without H. pylori
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Hamamatsu University School of Medicine
Hamamatsu, 431-3192
Mitsushige Sugimoto, +81-53-435-2261, mitsu@hama-med.ac.jp
About this study
Official title: Effects of Pro-Inflammatory and Anti-Inflammatory Cytokine Gene Polymorphism on the Development of Gastric Cancer and Peptic Ulcer in Japanese
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.
Read the detailed description
- 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.
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Gastric Cancer
- Being tested
- IL-1, TNF-alpha, Il-10
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-1, TNF-alpha, Il-10Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Collaborators
- Yokoyama Foundation for Clinical Pharmacology
- Investigators
- MItsushige Sugimoto, Study chair, First department of medicine, Hamamatsu University School of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197470
- Sponsor's protocol ID
- Mitsu-001
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pro-Inflammatory and Anti-Inflammatory Cytokine Gene Polymorphism on the Development of Gastric Cancer and Peptic Ulcer in Japanese
- ClinicalTrials.gov ID
- NCT00197470
- Acronym / sponsor ID
- Mitsu-001
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Collaborators
- Yokoyama Foundation for Clinical Pharmacology
- Study start
- Jan 2000
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- patinets without H. pylori
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-1, TNF-alpha, Il-10 | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MItsushige Sugimoto study chair
First department of medicine, Hamamatsu University School of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IL-1, TNF-alpha, Il-10 in people with Gastric Ulcer and Duodenal Ulcer, run by Hamamatsu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitsushige Sugimoto (+81-53-435-2261, mitsu@hama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.