UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040910 |
|---|---|
| Receipt number | 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 | 2023/07/28 06:20:33 |
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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
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
makira1980@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 09 | Day |
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
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045680
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