UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000191 |
|---|---|
| Receipt number | 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 20:01:54 |
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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
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
dsaitoh@ncc.go.jp
Sponsor or person
Institute
Second-Term Comprehensive 10-Years Strategy for Cancer Control (Ministry of Health and Welfare of Japan):Cancer Prevention
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000260
