UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031997 |
|---|---|
| Receipt number | 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 17:25:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mtajika@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
