UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Multicenter Retrospective Study of Endoscopic Resection in Patients with Squamous-cell Carcinoma of the Esophagus with Histopathological Invasion of the Muscularis Mucosa (MM) or Submucosa to a Depth of Up to 200 Micrometre (SM1)
Title of the study (Brief title)	Multicenter Study of MM/SM1 Squamous-cell Carcinoma of the Esophagus
Region	Japan

Condition
Condition	Esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the outcomes of endoscopic resection for MM/SM1 squamous-cell carcinoma of the esophagus by analyzing the clinical information on 985 patients in 9 hospitals who were reported at Panel Discussion 18 - Treatment Strategy After Endoscopic Resection of MM/SM1 Squamous-cell Carcinoma of the Esophagus - of the 93rd Annual Meeting of the Japan Gastroesophageal Endoscopy Society on May 12, 2017 (Osaka International Convention Center).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Clinicopathological characteristics 2. Description of additional treatment 3. Overall survival rates, relapse-free survival rates, and disease-specific survival rates (for all patients and according to invasion depth and the presence or absence of additional treatment) 4. Risk factors for recurrence 5. Clinical course of patients with recurrence
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The study group comprised patients who were reported at Panel Discussion 18 - Treatment Strategy After Endoscopic Resection of MM/SM1 Squamous-cell Carcinoma of the Esophagus - of the 93rd Annual Meeting of the Japan Gastroesophageal Endoscopy Society on May 12, 2017 (Osaka International Convention Center). In other words, we studied patients who underwent endoscopic resection of MM/SM1 squamous-cell carcinoma of the esophagus between August 1, 1992 and April 30, 2016.
Key exclusion criteria	None
Target sample size	985

Research contact person
Name of lead principal investigator	Chikatoshi Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL	042-778-8111
Email	ckatada@med.kitasato-u.ac.jp

Public contact
Name of contact person	Chikatoshi Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine, Department of Gastroenterology
Institute
Department

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)

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 12 Month 17 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 06 Month 06 Day
Anticipated trial start date	2018 Year 12 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Multicenter retrospective cohort study

Management information
Registered date	2018 Year 12 Month 16 Day
Last modified on	2018 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040180