UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002321
Receipt No. R000002837
Scientific Title Helicobacter pyloris and quamous cell carcinoma of esophagus : Case-Control study
Date of disclosure of the study information 2009/10/01
Last modified on 2016/03/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Helicobacter pyloris and quamous cell carcinoma of esophagus : Case-Control study
Acronym Helicobacter pyloris and quamous cell carcinoma of esophagus : Case-Control study
Scientific Title Helicobacter pyloris and quamous cell carcinoma of esophagus : Case-Control study
Scientific Title:Acronym Helicobacter pyloris and quamous cell carcinoma of esophagus : Case-Control study
Region
Japan

Condition
Condition squamous cell carcinoma of esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prevalense and mortality rate of esophageal carcinoma has increased. Some report show that mortality rate of squamous cell carcinoma of esophagus is in proportion to atrophic gastritis. Helicobacter pylori related to atrophic gastritis may increase risk of squamous cell carcinoma of esophagus.
Basic objectives2 Others
Basic objectives -Others Prevalense and mortality rate of esophageal carcinoma has increased. Some report show that mortality rate of squamous cell carcinoma of esophagus is in proportion to atrophic gastritis. Helicobacter pylori related to atrophic gastritis may increase risk of squamous cell carcinoma of esophagus.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient which was diagnosed is case group. Patient which match to age and sex is control group. We check serum Helicobacter pylori IgG antibody and make a comparative study.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Patient who fills everything the following

1) Patient of 20 years or more
2) Patient who gives written informed consent
Key exclusion criteria Patient who does not written informed consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Inamori
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
Homepage URL
Email

Sponsor
Institute Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2009 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2009 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2009 Year 08 Month 11 Day
Last modified on
2016 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.