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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000191
Receipt No. R000000260
Scientific Title Study on Prevention of Gastric Cancer by Early Detection of Helicobacter pylori Infection and Its Eradication(2nd-Term Comprehensive 10-Year Strategy for Cancer Control from the Ministry of Health and Welfare of Japan)
Date of disclosure of the study information 2007/01/31
Last modified on 2005/09/12

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Basic information
Public title Study on Prevention of Gastric Cancer by Early Detection of Helicobacter pylori Infection and Its Eradication(2nd-Term Comprehensive 10-Year Strategy for Cancer Control from the Ministry of Health and Welfare of Japan)
Acronym JITHP: Japanese Intervention Trial of H. pylori.
Scientific Title Study on Prevention of Gastric Cancer by Early Detection of Helicobacter pylori Infection and Its Eradication(2nd-Term Comprehensive 10-Year Strategy for Cancer Control from the Ministry of Health and Welfare of Japan)
Scientific Title:Acronym JITHP: Japanese Intervention Trial of H. pylori.
Region
Japan

Condition
Condition Gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study is designed to compare the development and progress of gastric mucosal atrophy in the patients of 20 to 59 years old without regional gastric lesions randomized into Helicobacter pylori ( H.pylori )-eradicated group or uneradicated group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The degree of atrophic gastritis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 * Lansoprazole(30mg/day x 7days)
* Clarithromycin(400mg/day x 7days)
* Amoxicillin(1,500mg/day x 7days)
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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria The patients who do not have the anamnesis of gastrointestinal ulcer or malignant gastric tumor endoscopically diagnosed to be H. pylori-positive in the cultivation of biopsy sample and who satisfy the following criteria are enrolled:
1) Hospitalized or out-patient:Irrespective
2) Age:20 to 59 years old
3) Sex:Irrespective
4) Patients who consented to be followed-up for 8 years
Key exclusion criteria 1) Patients who suffer from acuteulcer(AGML, etc,) and gastrointestinal ulcer (stage A1-S2)
2)Patients who suffer from pyloric stenosis, perforation, profuse hemorrhage, etc, and indications of surgical therapy
3)Patients with the anamnesis of gastrectomy or vagotomy
4)Patients with gastric adenoma or active malignant tumor in the stomach and other organs
5)Patients with severe complications (cardiac diseases, hepatic diseases, renal diseases, hematological diseases, etc.)
6)Patients who are the continuous users of possibly ulcerogenic drugs (for instance, steroids, non-steroids, salicylates, etc.)
7)Patients who are or may be pregnant, who are lactating and who wish to become pregnant before and after eradication treatment
8)Patients who have the anamnesis of hypersensitivity to antibiotics, proton pump inhibitors, or other drugs which will be used in the present study
9)Patients who have been judged by the physician in charge to be inappropriate as subjects from other reasons


Target sample size 750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daizo Saito
Organization National Cancer Center Hospital(NCCH)
Division name Endoscopy Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daizo Saito
Organization National Cancer Center Hospital(NCCH)
Division name Endoscopy Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email dsaitoh@ncc.go.jp

Sponsor
Institute Second-Term Comprehensive 10-Years Strategy for Cancer Control (Ministry of Health and Welfare of Japan):Cancer Prevention
Institute
Department

Funding Source
Organization Second-Term Comprehensive 10-Years Strategy for Cancer Control (Ministry of Health and Welfare of Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2007 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
1995 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
1995 Year 09 Month 01 Day
Last follow-up date
2004 Year 09 Month 01 Day
Date of closure to data entry
2004 Year 09 Month 01 Day
Date trial data considered complete
2004 Year 09 Month 01 Day
Date analysis concluded
2005 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2005 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000260

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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