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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015109
Receipt No. R000017571
Scientific Title Examination of small intestinal polyps using capsule endoscopy and balloon-assisted endoscopy for patients with familial polyposis syndrome
Date of disclosure of the study information 2014/09/10
Last modified on 2020/08/28

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Basic information
Public title Examination of small intestinal polyps using capsule endoscopy and balloon-assisted endoscopy for patients with familial polyposis syndrome
Acronym Examination of small intestinal polyps using capsule endoscopy and balloon-assisted endoscopy for patients with familial polyposis syndrome
Scientific Title Examination of small intestinal polyps using capsule endoscopy and balloon-assisted endoscopy for patients with familial polyposis syndrome
Scientific Title:Acronym Examination of small intestinal polyps using capsule endoscopy and balloon-assisted endoscopy for patients with familial polyposis syndrome
Region
Japan

Condition
Condition Familial adenomatous polyposis(FAP)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We will investigate the prevalence and clinical characteristics of small intestinal polyps using CE in a large cohort of FAP patients. We also will perform histological evaluation of the polyps using BA endoscopy and investigate risk factors for adenoma with high-grade dysplasia and cancer in the small intestine. Moreover, we will examine germline APC gene variants and analyze the genotype-phenotype correlation in patients with FAP.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes findings by CE and BA endoscopy, genetic information, medical records data
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene Maneuver
Interventions/Control_1 We will perform histological evaluation of the small intestinal polyps using BA endoscopy. We also will examine germline APC gene variants.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients 15 years of age or older who had an established diagnosis of FAP.
2) Patients who have no stenotic lesions in the gastrointestinal tract.
Key exclusion criteria 1) Patients who have a history of bowel obstruction, an installed cardiac pacemaker, or other electromedical devices.
2) Patients whose bowel movement is expected to be reduced due to systemic diseases such as diabetes, systemic scleroderma, etc..
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tetsuji
Middle name
Last name Takayama
Organization Tokushima university hospital
Division name Department of Gastroenterology and Oncology
Zip code 770-8503
Address 2-50-1 Kuramoto,Tokushima Japan
TEL 088-633-7124
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Kumiko
Middle name
Last name Tanaka
Organization Tokushima university hospital
Division name Department of Gastroenterology and Oncology
Zip code 770-8503
Address 2-50-1 Kuramoto,Tokushima Japan
TEL 088-633-7124
Homepage URL
Email tanaka.kumiko.1@tokushima-u.ac.jp

Sponsor
Institute Tokushima university hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokushima university hospital clinical trial center for developmental thetapeutics
Address 2-50-1 Kuramoto,Tokushima Japan
Tel 088-633-9294
Email first-ec@tokushima-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
2014 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 10 Day
Date of IRB
2014 Year 09 Month 10 Day
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2020 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017571

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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