Clinical Trial

Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

Not Yet Recruiting
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Record status
This record was last updated January 6, 2026 (before its estimated June 20, 2026 completion). Its status may not reflect the trial's current state.
Summary
Depressive symptoms are highly prevalent in patients with chronic atrophic gastritis (CAG) but are frequently under-detected due to stigma and reliance on subjective questionnaires. This multicenter, cross-sectional observational study aims to validate a novel clinical triage workflow. It repurposes routine vascular assessments (specifically dorsalis pedis artery ultrasound and arterial stiffness metrics) as objective "biological entry points" to facilitate mental health referrals. The study will enroll approximately 450-520 adults with histologically confirmed CAG across four clinical centers in China. The primary objective is to determine the diagnostic accuracy of these vascular biomarkers for identifying patients with moderate-to-severe depressive symptoms (PHQ-9 score \>= 10). Secondary objectives include evaluating the implementation feasibility (e.g., referral uptake, screening completion rate) of this integrated care model in routine gastroenterology practice.
Trial Details
NCT Number NCT07319338
Lead Sponsor China Academy of Chinese Medical Sciences
Collaborators: Beijing Anzhen Hospital, Hengshui Hospital of Traditional Chinese Medicine, Liyang Hospital of Traditional Chinese Medicine
Conditions Chronic Atrophic Gastritis, Depressive Symptoms, Depression, Gastrointestinal Diseases
Enrollment 520 participants
Start Date 2026-02-01
Primary Completion 2026-06-20 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-06