UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035268 |
|---|---|
| Receipt number | 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 00:40:46 |
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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
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
ckatada@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040180
