Chronic Atrophic GastritisNCT07319338
Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis
An observational study of Chronic Atrophic Gastritis and Depressive Symptoms, run by China Academy of Chinese Medical Sciences at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Atrophic Gastritis, Depressive Symptoms, Depression
- What is being tested?
- Vascular-Psychological Triage Workflow
- How many people
- 520 participants
- Where
- 4 sitesChina
- Study dates
- 1 Feb 2026to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of adult patients (aged 20-60 years) with histologically confirmed chronic atrophic gastritis (CAG). Participants are recruited from the gastroenterology outpatient clinics of four participating centers in Northern and Eastern China (including China Academy of Chinese Medical Sciences, Beijing Anzhen Hospital, Hengshui Hospital of TCM, and Liyang Hospital of TCM). All participants must have undergone upper gastrointestinal endoscopy within the past 6 months.
Who may be able to join
- Age between 20 and 60 years, regardless of sex.
- Diagnosed with chronic atrophic gastritis (CAG) confirmed by upper gastrointestinal endoscopy and histopathology within the past 6 months.
- Ability to comprehend and voluntarily complete psychological assessments and multimodal vascular examinations.
- Willingness to provide written informed consent.
Who cannot join
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder) or currently experiencing an acute psychotic episode.
- Major cardiovascular or cerebrovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months.
- Severe peripheral artery disease or major anatomical abnormalities in the lower extremities (e.g., Fontaine stage III-IV, diabetic foot with ulcers) that would preclude reliable dorsalis pedis artery ultrasound assessment.
- Severe hepatic or renal dysfunction, or malignancy with a limited life expectancy.
- Current use of systemic corticosteroids or potent immunosuppressants.
- Pregnancy or lactation.
- Any other condition deemed by the investigators to interfere with study participation or cooperation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700
Chao Wang, Dr, +86 13051167862, wangchao19891216@163.com
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Chao Wang, Dr, +86 13051167862, wangchao19891216@163.com
Liyang Hospital of Chinese Medicine
Changzhou, Jiangsu
Chao Wang, Dr, +86 13051167862, wangchao19891216@163.com
Hengshui Hospital of Traditional Chinese Medicine
Hengshui, Hebei, 053000
Chao Wang, Dr, +86 13051167862, wangchao19891216@163.com
About this study
Official title: Implementing Objective Vascular Biomarkers as a Non-stigmatizing Triage Workflow for Depression in Gastroenterology Settings: a Multicenter Study Protocol for a Hybrid Effectiveness-implementation Study
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.
Read the detailed description
Current screening for depression in gastroenterology relies heavily on self-report scales, which are often limited by somatization and cultural stigma in Asian populations. This study proposes a "vascular-gut-brain" framework to bridge this service gap.
Participants will undergo a standardized multimodal assessment comprising:
- Gastrointestinal evaluation: Endoscopy and histopathology (OLGA/OLGIM staging), and symptom scoring (GSRS).
- Peripheral vascular assessment: High-frequency ultrasound of the dorsalis pedis artery (measuring Resistive Index [RI], Pulsatility Index [PI], and waveform classification).
- Arterial stiffness and autonomic function: Brachial-ankle pulse wave velocity (baPWV), Ankle-Brachial Index (ABI), and Heart Rate Variability (HRV).
- Psychological assessment: PHQ-9, GAD-7, and PSQI scales.
The study employs a hybrid effectiveness-implementation design. In addition to validating the diagnostic accuracy of vascular markers, the study will assess the feasibility of the workflow. A subset of participants will be re-contacted at 3 months to evaluate referral completion and retention rates. The ultimate goal is to establish a non-stigmatizing, objective triage protocol to improve mental health resource utilization in digestive clinics.
- Being tested
- Vascular-Psychological Triage Workflow
- Keywords
- Vascular biomarkers, Dorsalis pedis artery ultrasound, Triage workflow, Implementation science, Stigma, Screening, Gut-brain axis
- Medical subject headings
- Gastritis, Atrophic, Depression, Gastrointestinal Diseases, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular-Psychological Triage WorkflowDiagnostic test
Participants undergo a multimodal assessment including high-frequency ultrasound of the dorsalis pedis artery, measurement of brachial-ankle pulse wave velocity (baPWV), and completion of the PHQ-9 depression screening scale.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic Atrophic Gastritis (CAG) | Adults (aged 20-60 years) with histologically confirmed chronic atrophic gastritis diagnosed via upper gastrointestinal endoscopy within the past 6 months. Receives: Diagnostic Test: Vascular-Psychological Triage Workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)
The primary outcome is the binary classification of depressive symptom burden. Participants are categorized as "screen-positive" if their 9-item Patient Health Questionnaire (PHQ-9) total score is ≥10, indicating moderate-to-severe depressive symptoms warranting referral. The PHQ-9 scores range from 0 to 27, with higher scores indicating greater symptom severity.
Measured: Baseline (Day 0)
Secondary outcomes (8)
Screening Completion Rate
The proportion of eligible patients consenting to assessment.
Measured: Up to 3 months
Referral Uptake Rate
The proportion of screen-positive patients completing mental health consultation.
Measured: Up to 3 months
Dorsalis Pedis Artery Resistive Index (RI)
A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound.
Measured: Baseline (Day 0)
Dorsalis Pedis Artery Pulsatility Index (PI)
A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound.
Measured: Baseline (Day 0)
Dorsalis Pedis Artery Flow Waveform Classification
Flow waveforms classified into three categories: triphasic, biphasic, or monophasic via Doppler ultrasound assessment.
Measured: Baseline (Day 0)
Brachial-Ankle Pulse Wave Velocity (baPWV)
Measured to assess arterial stiffness.
Measured: Baseline (Day 0)
Generalized Anxiety Disorder-7 (GAD-7) Score
Anxiety symptom severity assessed using the GAD-7 scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline (Day 0)
Time Burden
The median time added to routine workflow (measured in minutes)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Atrophic GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Hengshui Hospital of Traditional Chinese Medicine, Liyang Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Meng Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319338
- Sponsor's protocol ID
- 2025-EC-KY-004
- Other IDs
- Other Identifier
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification, may be shared with researchers who provide a methodologically sound proposal and obtain necessary ethical approvals. Data sharing is subject to the rules and regulations of the participating institutions and the Data Security Law of China.
Publications
Wang M, Jiang S, Jin Z, Pan X, Xu S, Wang C. Vascular and autonomic correlates of screening-positive depressive symptom burden in chronic atrophic gastritis: a multicenter observational study protocol. Front Med (Lausanne). 2026 May 5;13:1842882. doi: 10.3389/fmed.2026.1842882. eCollection 2026.
PubMed 42164162
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Objective Vascular Biomarkers as a Non-stigmatizing Triage Workflow for Depression in Gastroenterology Settings: a Multicenter Study Protocol for a Hybrid Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT07319338
- Acronym / sponsor ID
- 2025-EC-KY-004
- Keywords
- Vascular biomarkers, Dorsalis pedis artery ultrasound, Triage workflow, Implementation science, Stigma, Screening, Gut-brain axis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Hengshui Hospital of Traditional Chinese Medicine, Liyang Hospital of Traditional Chinese Medicine
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current screening for depression in gastroenterology relies heavily on self-report scales, which are often limited by somatization and cultural stigma in Asian populations. This study proposes a "vascular-gut-brain" framework to bridge this service gap.
Participants will undergo a standardized multimodal assessment comprising:
- Gastrointestinal evaluation: Endoscopy and histopathology (OLGA/OLGIM staging), and symptom scoring (GSRS).
- Peripheral vascular assessment: High-frequency ultrasound of the dorsalis pedis artery (measuring Resistive Index [RI], Pulsatility Index [PI], and waveform classification).
- Arterial stiffness and autonomic function: Brachial-ankle pulse wave velocity (baPWV), Ankle-Brachial Index (ABI), and Heart Rate Variability (HRV).
- Psychological assessment: PHQ-9, GAD-7, and PSQI scales.
The study employs a hybrid effectiveness-implementation design. In addition to validating the diagnostic accuracy of vascular markers, the study will assess the feasibility of the workflow. A subset of participants will be re-contacted at 3 months to evaluate referral completion and retention rates. The ultimate goal is to establish a non-stigmatizing, objective triage protocol to improve mental health resource utilization in digestive clinics.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Atrophic Gastritis (CAG) | – | Diagnostic Test: Vascular-Psychological Triage WorkflowAdults (aged 20-60 years) with histologically confirmed chronic atrophic gastritis diagnosed via upper gastrointestinal endoscopy within the past 6 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of adult patients (aged 20-60 years) with histologically confirmed chronic atrophic gastritis (CAG). Participants are recruited from the gastroenterology outpatient clinics of four participating centers in Northern and Eastern China (including China Academy of Chinese Medical Sciences, Beijing Anzhen Hospital, Hengshui Hospital of TCM, and Liyang Hospital of TCM). All participants must have undergone upper gastrointestinal endoscopy within the past 6 months.
Key inclusion criteria (4 listed)
- Age between 20 and 60 years, regardless of sex.
- Diagnosed with chronic atrophic gastritis (CAG) confirmed by upper gastrointestinal endoscopy and histopathology within the past 6 months.
- Ability to comprehend and voluntarily complete psychological assessments and multimodal vascular examinations.
- Willingness to provide written informed consent.
Key exclusion criteria (7 listed)
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder) or currently experiencing an acute psychotic episode.
- Major cardiovascular or cerebrovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months.
- Severe peripheral artery disease or major anatomical abnormalities in the lower extremities (e.g., Fontaine stage III-IV, diabetic foot with ulcers) that would preclude reliable dorsalis pedis artery ultrasound assessment.
- Severe hepatic or renal dysfunction, or malignancy with a limited life expectancy.
- Current use of systemic corticosteroids or potent immunosuppressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular-Psychological Triage WorkflowParticipants undergo a multimodal assessment including high-frequency ultrasound of the dorsalis pedis artery, measurement of brachial-ankle pulse wave velocity (baPWV), and completion of the PHQ-9 depression screening scale. | Diagnostic test | Patients with Chronic Atrophic Gastritis (CAG) |
Primary outcome
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)
Time frame: Baseline (Day 0)
The primary outcome is the binary classification of depressive symptom burden. Participants are categorized as "screen-positive" if their 9-item Patient Health Questionnaire (PHQ-9) total score is ≥10, indicating moderate-to-severe depressive symptoms warranting referral. The PHQ-9 scores range from 0 to 27, with higher scores indicating greater symptom severity.
8 secondary outcomes
Screening Completion Rate
Time frame: Up to 3 months
Referral Uptake Rate
Time frame: Up to 3 months
Dorsalis Pedis Artery Resistive Index (RI)
Time frame: Baseline (Day 0)
Dorsalis Pedis Artery Pulsatility Index (PI)
Time frame: Baseline (Day 0)
Dorsalis Pedis Artery Flow Waveform Classification
Time frame: Baseline (Day 0)
Brachial-Ankle Pulse Wave Velocity (baPWV)
Time frame: Baseline (Day 0)
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline (Day 0)
Time Burden
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 42164162Wang M, Jiang S, Jin Z, Pan X, Xu S, Wang C. Vascular and autonomic correlates of screening-positive depressive symptom burden in chronic atrophic gastritis: a multicenter observational study protocol. Front Med (Lausanne). 2026 May 5;13:1842882. doi: 10.3389/fmed.2026.1842882. eCollection 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification, may be shared with researchers who provide a methodologically sound proposal and obtain necessary ethical approvals. Data sharing is subject to the rules and regulations of the participating institutions and the Data Security Law of China.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Atrophic Gastritis and Depressive Symptoms, run by China Academy of Chinese Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Wang, PhD (+86 18852096726, nzzywm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10) (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.