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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031997
Receipt No. R000036440
Scientific Title LONG-TERM OUTCOME OF METACHRONOUS ADENOMAS AND CARCINOMAS IN THE ILEAL POUCH AND RECTUM AFTER SURGICAL TREATMENT IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS
Date of disclosure of the study information 2018/04/01
Last modified on 2019/03/21

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Basic information
Public title LONG-TERM OUTCOME OF METACHRONOUS ADENOMAS AND CARCINOMAS IN THE ILEAL POUCH AND RECTUM AFTER SURGICAL TREATMENT IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS
Acronym LONG-TERM OUTCOME OF ILEAL POUCH IN PATIENTS WITH FAP
Scientific Title LONG-TERM OUTCOME OF METACHRONOUS ADENOMAS AND CARCINOMAS IN THE ILEAL POUCH AND RECTUM AFTER SURGICAL TREATMENT IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS
Scientific Title:Acronym LONG-TERM OUTCOME OF ILEAL POUCH IN PATIENTS WITH FAP
Region
Japan

Condition
Condition FAMILIAL ADENOMATOUS POLYPOSIS
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluated the incidence of rectal adenomas, and also the ileal pouch and non-pouch adenomas and carcinomas in patients with familial adenomatous polyposis.
Basic objectives2 Others
Basic objectives -Others We evaluated the nature of rectal adenomas, and also the ileal pouch and non-pouch adenomas and carcinomas in patients with familial adenomatous polyposis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of rectal adenomas,the ileal pouch, and non-pouch adenomas and carcinomas in patients with familial adenomatous polyposis.
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria FAP patients who undergone surgery and endscopic surveillance in our hospital.
Key exclusion criteria FAP patients who did not undergone surgery and endscopic surveillance in our hospital.
Target sample size 47

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tajika
Organization Aichi Cancer Center Hospital
Division name Department of Endoscopy
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Email mtajika@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tajika
Organization Aichi Cancer Center Hospital
Division name Department of Endoscopy
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Homepage URL
Email mtajika@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 04 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 Completed
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2018 Year 04 Month 19 Day
Anticipated trial start date
2018 Year 04 Month 20 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohot study

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036440

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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