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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029927
Receipt No. R000033991
Scientific Title The study of treatment guidelines of gastric carcinoid with type A chronic atrophic gastritis.
Date of disclosure of the study information 2018/01/01
Last modified on 2019/05/13

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Basic information
Public title The study of treatment guidelines of gastric carcinoid with type A chronic atrophic gastritis.
Acronym Treatment guidelines of gastric carcinoid
Scientific Title The study of treatment guidelines of gastric carcinoid with type A chronic atrophic gastritis.
Scientific Title:Acronym Treatment guidelines of gastric carcinoid
Region
Japan

Condition
Condition Gastric carcinoid with type A gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Establish appropriate treatment guideline and clarify the long-term prognosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Long-term prognosis according to the treatment method
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) positive anti-parietal cell antibody or 2) presence of fundic gland atrophy and hyperplasia of ECL cells or 3) evidence of hypergastrinemia (>450pg/ml)
Key exclusion criteria no evidence of multiple endocrine neoplasia (MEN)-Zollinger-ellison syndrome
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Haruma
Organization Kawasaki Medical School
Division name General Internal Medicine 2
Zip code 7008505
Address 2-6-1, Nakasannge, Kita-ku, Okayama
TEL 086-225-2111
Email kharuma@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Tomoari
Middle name
Last name Kamada
Organization Kawasaki Medical School
Division name Dept. of Health Care Medicine
Zip code 7008505
Address 2-6-1, Nakasannge, Kita-ku, Okayama
TEL 086-225-2111
Homepage URL
Email tkamada@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Japan Gastroenterological Endoscopy Society
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 Kawasaki Medical School
Address 2-6-1, Nakasannge, Kita-ku, Okayama
Tel 086-225-2111
Email tkamada@med.kawasaki-m.ac.jp

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
2018 Year 01 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 10 Day
Date of IRB
2017 Year 12 Month 05 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 11 Month 10 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033991

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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