Tokyo, Feb. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060761) titled 'Relationship Between White Opaque Substance Observed by Magnifying NBI Endoscopy Under Intragastric Neutralization and Gastric Cancer Risk: A Pilot Study' on Feb. 26.
Study Type:
Observational
Primary Sponsor:
Institute - Fukuoka University
Condition:
Condition - Chronic gastritis, gastric intestinal metaplasia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the association between WOS and gastric cancer under gastric acid-neutralized conditions.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Inclusion criteria for the gastric cancer group
1. Patients with a histologically confirmed diagnosis of gastric cancer based on biopsy.
2. Patients who require upper gastrointestinal endoscopy at Fukuoka University Chikushi Hospital for the treatment or further evaluation of gastric cancer.
3. Patients aged 20 years or older.
4. Patients who have been receiving any proton pump inhibitor for at least 1 week.
5. Patients who have provided written informed consent for study participation.
Inclusion criteria for the non-gastric cancer group
1. Patients who require upper gastrointestinal endoscopy at Fukuoka University Chikushi Hospital for any reason.
2. Patients with no prior history of gastric cancer.
3. Patients aged 20 years or older.
4. Patients who have been receiving any proton pump inhibitor for at least 1 week.
5. Patients who have provided written informed consent for study participation.
Key exclusion criteria - 1. Patients in whom adequate observation of the gastric mucosa is difficult.
2. Patients with a history of gastrectomy.
3. Patients at high risk of bleeding from biopsy due to underlying conditions such as hepatic dysfunction, renal dysfunction, or coagulation disorders.
4. Patients in whom biopsy cannot be performed due to the use of anticoagulant or antiplatelet agents.
Target Size - 200
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 07 Day
Date of IRB - 2025 Year 07 Month 07 Day
Anticipated trial start date - 2025 Year 07 Month 23 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067471
Disclaimer: Curated by HT Syndication.
