Tokyo, June 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061932) titled 'Association of gastric mucosal atrophy and upper gastrointestinal microbiota with esophageal squamous neoplasia: a prospective observational study' on June 16.
Study Type:
Observational
Primary Sponsor:
Institute - Akita University
Condition:
Condition - Esophageal squamous neoplasia (esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia)
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - The objective of this study is to investigate the association of gastric mucosal atrophy and upper gastrointestinal microbiota with esophageal squamous neoplasia. In particular, this study aims to prospectively evaluate how the degree of gastric mucosal atrophy and structural characteristics of the esophageal microbiota are associated with the presence of esophageal squamous neoplasia.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - -Adults aged 18 years or older
-Individuals undergoing clinically indicated upper gastrointestinal endoscopy
-Participants who meet one of the following criteria:
(i) Patients with newly diagnosed superficial esophageal squamous neoplasia (esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia)
(ii) Control patients without esophageal squamous neoplasia
-Provision of written informed consent
Key exclusion criteria - -Patients with advanced esophageal cancer
-History of esophageal squamous neoplasia
-Patients with esophageal obstruction
-Receipt of chemotherapy or radiotherapy within 6 months
-Use of antibiotics within 8 weeks
-Initiation or dose change of acid-suppressive medications or probiotics within 8 weeks
-Participants judged to be ineligible by the investigator
-Lack of or withdrawal of informed consent
Target Size - 140
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 06 Month 12 Day
Date of IRB - 2026 Year 06 Month 12 Day
Anticipated trial start date - 2026 Year 06 Month 16 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070868
Disclaimer: Curated by HT Syndication.
