UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015740 |
|---|---|
| Receipt number | R000018283 |
| Scientific Title | Prospective multicenter study of persistent recurrence rate and the optimal observation time after endoscopic piecemeal mucosal resection for colorectal neoplaisa |
| Date of disclosure of the study information | 2014/11/24 |
| Last modified on | 2014/11/22 12:05:33 |
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Basic information
Public title
Prospective multicenter study of persistent recurrence rate and the optimal observation time after endoscopic piecemeal mucosal resection for colorectal neoplaisa
Acronym
RCT study after EPMR
Scientific Title
Prospective multicenter study of persistent recurrence rate and the optimal observation time after endoscopic piecemeal mucosal resection for colorectal neoplaisa
Scientific Title:Acronym
RCT study after EPMR
Region
| Japan | Asia(except Japan) |
Condition
Condition
Colorectal neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify proper observation period after endoscopic piecemeal mucosal resection for colorectal neoplasia
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of each of the local recurrence rate during follow-up in 3 months and in six months after endoscopic piecemeal mucosal resection
Key secondary outcomes
In 24 months after EPMR, cumulative additional surgical resection rate and local remnant recurrence rate
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
interval of colonoscopy examination is 3 month
Interventions/Control_2
interval of colonoscopy examination is 6 month
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases after EPMR for colorectal neoplasia with curative resection
Key exclusion criteria
1.Informed Consent (IC) rejection patient
2.Patients in chemotherapy and/or radiation therapy with cancer, including the other organs.
3.If the attending physician has determined that the inappropriate registration to this study.
4. hyperplastic polyp, including the large hyperplastic polyp
5. After diagnosed non-curative resection endoscopically and histopathologically, patients who never enforced additional surgical resection and observation has been selected
6.systemic state failure patients due to other organ failure
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUTAKA SAITO |
Organization
NATIONAL CANCER CENTER HOSPITAL
Division name
ENDOSCOPY DIVISION
Zip code
Address
5-1-1,Tsukiji, Chuo-ku,TOKYO
TEL
+81335422511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKESHI NAKAJIMA |
Organization
NATIONAL CANCER CENTER HOSPITAL
Division name
ENDOSCOPY DIVISION
Zip code
Address
5-1-1,Tsukiji, Chuo-ku,TOKYO
TEL
+81335422511
Homepage URL
tnakajim@ncc.go.jp
Sponsor or person
Institute
NATIONAL CANCER CENTER
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 11 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2014 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018283
