Status:
UNKNOWN
Application of OE in Diagnosis of EGC
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Qilu Hospital of Shandong University
Shengjing Hospital
Conditions:
High Risk Population of Gastric Cancer
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentia...
Detailed Description
Gastric cancer is the most prevalent cancer in China，while the detection rate of early gastric cancer is lower than 10%. An effective screening method to improve the detection rate is urgently needed....
Eligibility Criteria
Inclusion
- Meet item 1or 2 + any items of 3-7
- Male ≥ 40 years old, female ≥ 50 years old.
- More than one year since the last gastroscopy.
- Patients from the areas with high incidence of stomach cancer (Shandong Province, Liaoning Province, Fujian Province, Gansu Province, Qinghai Province, Ningxia Province, Jilin Province, Jiangsu Province, Shanghai).
- Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past.
- First-degree relatives of patients with a family history of gastric cancer.
- Other high-risk life factors for gastric cancer (high salt, pickled diet, smoking, heavy alcohol consumption, etc.)
- Positive serum gastric function tests (GastroPanel) include: H. pylori (H.P) antibody （+）, Fasting pepsinogen I and II ratio (PG I/PGII) \<3.89, gastrin 17 (G-17) \>1.50 pmol/L.
Exclusion
- Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD).
- Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。
- Patients on anticoagulants that cannot be biopsied.
- Patients who have undergone gastrectomy.
- Patients who have taken PPIs or H2 receptor antagonist within two weeks.
- Patients with history of malignant neoplasm; high suspicion of neoplasm; severe cardiac, pulmonary, hepatic or renal insufficiency; severe mental illness and pregnant women.
- Patients who did not signed the consent form.
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 10 2021
Estimated Enrollment :
2454 Patients enrolled
Trial Details
Trial ID
NCT04720521
Start Date
May 10 2019
End Date
May 10 2021
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China, 200433