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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040910
Receipt No. R000045680
Scientific Title Establishment of a system for treatment selection in patients aged 80 years or older with early gastric cancer and superficial esophageal cancer.
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/26

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Basic information
Public title Establishment of a system for treatment selection in patients aged 80 years or older with early gastric cancer and superficial esophageal cancer.
Acronym E-STAGE TRIAL
Scientific Title Establishment of a system for treatment selection in patients aged 80 years or older with early gastric cancer and superficial esophageal cancer.
Scientific Title:Acronym E-STAGE TRIAL
Region
Japan

Condition
Condition superficial esophageal cancer and early gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a system for treatment selection including geriatric assessment for patients aged 80 years or older with superficial esophageal cancer and early gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Factors associated with 3-year mortality in patients with superficial esophageal cancer.
Factors associated with 3-year mortality in patients with early gastric cancer.
Key secondary outcomes 1) Overall survival in patients with superficial esophageal cancer and early gastric cancer.
2) Factors associated with 3-year mortality in upper gastrointestinal cancer (superficial esophageal cancer/early gastric cancer).
3) The decrease rate of QOL (symptom score) at 3 years after the treatment compared with the time of registration and factors associated with the lower QOL (symptom score) in patients with superficial esophageal cancer and early gastric cancer
4) Factors associated with lower QOL (symptom score) at 3 years after the treatment compared with the time of registration in patients with upper gastrointestinal cancer (superficial esophageal cancer/early gastric cancer).
5) Validation of the prediction model for 3-year overall survival in patients with early gastric cancer.
6) Validation of the prediction model for lower QOL (symptom score) at 3 years after the treatment in patients with early gastric cancer.
7) Difference between the prediction model for 3-year overall survival by artificial intelligence and that by statistical analysis.
8) Difference between the prediction model for lower QOL (symptom score) at 3 years after the treatment by artificial intelligence and statistical analysis.
9) Progression rate of cT stage of the lesions without treatment in patients with superficial esophageal cancer and early gastric cancer.
10) The incidence rate of metachronous cancers after endoscopic treatment in patients with superficial esophageal cancer and early gastric cancer
11) The 3-year skeletal muscle mass reduction rate and factors associated with the skeletal muscle mass reduction in patients with curability C-2 after endoscopic resection for early gastric cancer.
12) Validation of the eCura system in patients with curability C-2 after endoscopic resection for early gastric cancer.

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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients diagnosed as esophageal or gastric tumor by endoscopy.
(2) Patients diagnosed or suspected as carcinoma by biopsy or resected specimen.
(3) Patients with esophageal/gastric cancers that confined to submucosa in clinical diagnosis.
(4) Patients with 80 years or older.
(5) Patients with written informed consent for study participation.
Key exclusion criteria (1) Patients who refuse to participate in the study.
(2) Patients with esophageal/gastric cancers invading into the muscularis propria in the resected specimen.
(3) Patients who are regarded as inappropriate by the investigator.
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Waku
Middle name
Last name Hatta
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7171
Email waku-style@festa.ocn.ne.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Maekawa
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku, Osaka. Osaka, Japan
TEL 06-6945-1181
Homepage URL
Email makira1980@gmail.com

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Gastroenterological Endoscopy Society
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 the Ethics Committee of Tohoku University Hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel 022-728-4105
Email ec@rinri.hosp.tohoku.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
2020 Year 07 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2025 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we perform geriatric assessment at the time of registration for patients aged 80 years or older with superficial esophageal cancer and early gastric cancer. We evaluate the several factors associated with 3-year mortality and lower QOL (symptom score) and validate the prediction model for 3-year overall survival and lower QOL.
Based on the results, we aim to establish a system for treatment selection including geriatric assessment for patients aged 80 years or older with superficial esophageal cancer and early gastric cancer.

Management information
Registered date
2020 Year 06 Month 26 Day
Last modified on
2020 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045680

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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