UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000017571