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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044010
Receipt No. R000050201
Scientific Title A prospective study on the social perception of Barrett's esophagus
Date of disclosure of the study information 2021/04/26
Last modified on 2021/04/21

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Basic information
Public title A prospective study on the social perception of Barrett's esophagus
Acronym A prospective study on the social perception of Barrett's esophagus
Scientific Title A prospective study on the social perception of Barrett's esophagus
Scientific Title:Acronym A prospective study on the social perception of Barrett's esophagus
Region
Japan

Condition
Condition Barrett's esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the awareness of Barrett's esophagus in Japan.
Basic objectives2 Others
Basic objectives -Others Assessing HRQoL in patients with Barrett's esophagus using various questionnaires
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cancer worry scale
Key secondary outcomes Short form-8 scale, Frequency scale for the symptoms of GERD

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
85 years-old >
Gender Male and Female
Key inclusion criteria Barrett's esophagus patients
Key exclusion criteria Those who could not answer the questionnaire
Target sample size 500

Research contact person
Name of lead principal investigator
1st name SHO
Middle name
Last name FUKUDA
Organization Akita University Hospital
Division name gastroenterology
Zip code 010-8543
Address 44-2 Hiroomote Hasunuma, Akita, Akita
TEL 0188331166
Email s.fukuda@med.akita-u.ac.jp

Public contact
Name of contact person
1st name SHO
Middle name
Last name FUKUDA
Organization Akita University Hospital
Division name gastroenterology
Zip code 010-8543
Address 44-2 Hiroomote Hasunuma, Akita, Akita
TEL 0188331166
Homepage URL
Email s.fukuda@med.akita-u.ac.jp

Sponsor
Institute Akita University Hospital
Institute
Department

Funding Source
Organization Akita University Hospital
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 Akita University Graduate School of Medicine
Address 1-1-1, hondo, Akita, Akita
Tel 0188846573
Email info@hos.akita-u.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
2021 Year 04 Month 26 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 Enrolling by invitation
Date of protocol fixation
2021 Year 04 Month 01 Day
Date of IRB
2021 Year 03 Month 22 Day
Anticipated trial start date
2021 Year 04 Month 26 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A questionnaire will be administered after esophagogastroduodenoscopy. The results of the questionnaire will be evaluated as the primary endpoint.

Management information
Registered date
2021 Year 04 Month 21 Day
Last modified on
2021 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050201

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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