Establishment of a system for treatment selection in patients aged 80 years or older with early gastric cancer and superficial esophageal cancer.

Establishment of a system for treatment selection in patients aged 80 years or older with early gastric cancer and superficial esophageal cancer. - E-STAGE TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040910

Enrollment

1100

Registered

2020-07-01

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

superficial esophageal cancer and early gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Factors associated with 3-year mortality in patients with superficial esophageal cancer. Factors associated with 3-year mortality in patients with early gastric cancer.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactAkira Maekawa

Osaka International Cancer Institute Department of Gastrointestinal Oncology

makira1980@gmail.com06-6945-1181

Outcome results