UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044644 |
|---|---|
| Receipt number | R000050992 |
| Scientific Title | Multicenter retrospective observational study to compare Prognosis of Patients with T1 Colorectal cancer with high Risk of lymph node metastasis after endoscopic treatment between additional surgery and observatioN (the POPCORN Study) |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2021/06/24 18:43:20 |
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Basic information
Public title
Multicenter retrospective observational study to compare Prognosis of Patients with T1 Colorectal cancer with high Risk of lymph node metastasis after endoscopic treatment between additional surgery and observatioN (the POPCORN Study)
Acronym
Multicenter retrospective observational study to compare Prognosis of Patients with T1 Colorectal cancer with high Risk of lymph node metastasis after endoscopic treatment between additional surgery and observatioN (the POPCORN Study)
Scientific Title
Multicenter retrospective observational study to compare Prognosis of Patients with T1 Colorectal cancer with high Risk of lymph node metastasis after endoscopic treatment between additional surgery and observatioN (the POPCORN Study)
Scientific Title:Acronym
Multicenter retrospective observational study to compare Prognosis of Patients with T1 Colorectal cancer with high Risk of lymph node metastasis after endoscopic treatment between additional surgery and observatioN (the POPCORN Study)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the long-term outcomes of the additional surgery group and the observation group in the patients after ESD (endoscopic submucosal dissection) for high-risk pT1 colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Relapse-free survival, Morbidity rate and rate of lymph node metastasis in the additional surgery group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who met one or more of the following criteria after ESD for pT1b colorectal cancer
1) SM invasion depth of more than 1000 um
2) positive vascular invasion
3) poorly differentiated adenocarcinoma, signet ring cell carcinoma, mucinous carcinoma
4) high grade tumor budding (Grade 2/ 3) at the SM invasive part
5) positive vertical margin
Key exclusion criteria
1) Patients who underwent EMR (Endoscopic mucosal resection) instead of ESD
2) Patients who is judged to be ineligible to participate in the study by the research principal doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Numata |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
numata@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Atsumi |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2800
Homepage URL
yosuke21@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
045-787-2800
rinri@yokohama-cu.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
| 2021 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050992
