UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015109 |
|---|---|
| Receipt number | 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 13:48:12 |
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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
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
tanaka.kumiko.1@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017571
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
