UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010155 |
|---|---|
| Receipt number | R000011892 |
| Scientific Title | Prospective cohort study to evaluate the effectiveness, safety and long prognosis of endoscopic submucosal dissection for colorectal tumor |
| Date of disclosure of the study information | 2013/03/04 |
| Last modified on | 2024/01/23 15:58:16 |
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Basic information
Public title
Prospective cohort study to evaluate the effectiveness, safety and long prognosis of endoscopic submucosal dissection for colorectal tumor
Acronym
Prospective cohort study to evaluate the effectiveness, safety and long prognosis of ESD for colorectal tumor
Scientific Title
Prospective cohort study to evaluate the effectiveness, safety and long prognosis of endoscopic submucosal dissection for colorectal tumor
Scientific Title:Acronym
Prospective cohort study to evaluate the effectiveness, safety and long prognosis of ESD for colorectal tumor
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness, safety and long prognosis of ESD for colorectal tumo
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of complete en bloc resection, complication and prognosis in patients with colorectal ESD
Key secondary outcomes
Prevalence of local/metastatic recurrence and rate of metachronous colorectal lesion after ESD
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Eendoscopic submucosal dissection for colorectal tumor
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Colorectal ESD cases
2)Early colorectal cancer (>20 mm in diameter) for which endoscopic treatment is indicative but for which en bloc resection by snare EMR would be difficult.
3) Adenoma with non-lifting sign (+) after injection during EMR procedures.
4)Local residual tumor after EMR (>10 mm in diameter) for which en bloc resection by snare EMR would be difficult.
Key exclusion criteria
non
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Haruhiro |
| Middle name | |
| Last name | Inoue |
Organization
Japan Gastroenterological Endoscopy Society
Division name
President
Zip code
101-0062
Address
3-2-1 Kanda surugadai, Chiyoda-ku, Tokyo
TEL
03-3542-4670
kaminishi.michio@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Gastroenterological Endoscopy Society
Address
Shin-ochanomizu Urban Trinity Bldg.4F, 3-2-1, Kandasurugadai, Chiyoda-ku,Tokyo, 101-0062, Japan
Tel
03-3291-4111
info@jges.or.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
| 2013 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/gee/57/6/57_1411/_article/-char/ja
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
537
Results
Results date posted
| 2023 | Year | 02 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to data collection in progress
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
| 2012 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011892
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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