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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035268
Receipt No. R000040180
Scientific Title 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)
Date of disclosure of the study information 2018/12/17
Last modified on 2018/12/16

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Basic information
Public title 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)
Acronym Multicenter Study of MM/SM1 Squamous-cell Carcinoma of the Esophagus
Scientific Title 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)
Scientific Title:Acronym 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
1st name
Middle name
Last name Chikatoshi Katada
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Chikatoshi Katada
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2018 Year 06 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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