UMIN-CTR Clinical Trial

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
Email	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
Email	yosuke21@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050992