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

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 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


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

Value
https://center6.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