Chronic Atrophic Gastritis (CAG)NCT06707701
Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis
An observational study of Chronic Atrophic Gastritis (CAG), run by Yi Liang at 1 site in China.
Trial summary
Brief Summary Template for the Study: The goal of this observational study is to examine the relationship between digestive symptom scores, serum pepsinogen indices, and histopathological OLGA and OLGIM systematic staging of the gastric mucosa in patients with chronic atrophic gastritis(CAG), aiming to determine the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Atrophic Gastritis (CAG)
- What is being tested?
- acupuncture
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involved the recruitment of CAG patients from endoscopy centers, outpatient clinics, and inpatient clinics within the Department of Splenology and Gastroenterology at Zhongshan Hospital in Zhejiang Province, designated as the primary recruitment center, along with the First People's Hospital of Hangzhou and Hangzhou Hospital of Traditional Chinese Medicine as secondary recruitment centers.
Who may be able to join
- Fulfill the diagnostic criteria for chronic atrophic gastritis;
- Individuals aged 18 to 75 years, irrespective of gender;
- Capable of comprehending and consenting to participate in this study by signing the informed consent form.
Who cannot join
- Autoimmune gastritis (type A chronic atrophic gastritis);
- Patients diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy or other examinations or patients diagnosed with high-grade intraepithelial neoplasia by upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
- Patients with confirmed or unable to exclude malignant tumors, especially esophageal and gastric cancers; patients with other upper gastrointestinal tract pathologies such as peptic ulcer or Barrett's esophagus;
- Those who cannot complete the questionnaire due to unconsciousness, inability to communicate normally or other reasons; those with incomplete information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
Hangzhou
Yi Liang, +86-571-86633328, liangyiwww@126.com
Han Zhang, 492660946@qq.com
About this study
Official title: Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis:a Multicenter Cross-sectional Pilot Survey
Brief Summary Template for the Study:
The goal of this observational study is to examine the relationship between digestive symptom scores, serum pepsinogen indices, and histopathological OLGA and OLGIM systematic staging of the gastric mucosa in patients with chronic atrophic gastritis(CAG), aiming to determine the degree of correlation between clinical manifestations, non-invasive laboratory tests, and the gold standard of diagnostic histopathology.To evaluate the comprehensive therapy, readiness and acceptance of acupuncture, utilization rates of various acupuncture therapies, self-assessed efficacy of acupuncture, and endoscopic histopathological alterations in patients with CAG.According to the aforementioned study, it is anticipated to enhance the optimization of acupuncture clinical research protocols for chronic atrophic gastritis, improve treatment efficacy, and offer more effective and rational therapy alternatives for patients.The main question it aims to answer is:
Read more
To determine if the outcomes of combined serologic testing of symptoms in patients with CAG can serve as a method for monitoring disease development and if long-term follow-up can be supported？
A group of participants with recorded GI symptom scores and blood pepsinogen levels will respond to online survey questions regarding the severity of their chronic atrophic gastritis progression over the course of 1 year.
Read the detailed description
This study is a multicenter cross-sectional pilot survey
- Conditions
- Chronic Atrophic Gastritis (CAG)
- Being tested
- acupuncture
- Keywords
- chronic atrophic gastritis, global overall symptom scale, serum pepsinogen, operative link for gastritis assessment, operative link for gastric intestinal metaplasia assessment
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Whether or not a patient has been treated with acupuncture will be one of the exposure factors of interest in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG
The investigators gathered clinical data on the overall condition, occupation, personal history, family history, H. pylori infection, gastrointestinal symptom scores, serum pepsinogen index, gastroscopy reports, pathological findings, and other biological characteristics of CAG patients, along with data pertaining to acupuncture treatment. The investigators then analyzed the correlation between the gastrointestinal symptom scores, the serum pepsinogen index, and the gastric mucosal histopathology OLGA and OLGIM. The investigators examined the relationship between gastrointestinal symptom scores, serum pepsinogen levels, and the histopathological OLGA and OLGIM stages of gastric mucosa to determine the correlation between clinical manifestations, non-invasive laboratory tests, and the definitive diagnostic standard of histopathology, thereby offering support for clinicians.
Measured: Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment
Secondary outcomes (1)
Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively
With the goal of further optimizing the clinical research protocols of acupuncture for CAG, improving the therapeutic effects, and offering a more effective and affordable treatment option for patients with chronic atrophic gastritis, the investigators examined the overall treatment of CAG patients, willingness and acceptance of acupuncture treatment, application rate of various acupuncture therapies, self-perceived acupuncture efficacy, and endoscopic histopathological changes.
Measured: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atrophic Gastritis (CAG)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Liang
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University of Science and Technology
- Responsible party
- Sponsor-investigator, Yi Liang, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707701
- Sponsor's protocol ID
- 20241102100617911
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis:a Multicenter Cross-sectional Pilot Survey
- ClinicalTrials.gov ID
- NCT06707701
- Acronym / sponsor ID
- 20241102100617911
- Conditions
- Chronic Atrophic Gastritis (CAG)
- Keywords
- chronic atrophic gastritis, global overall symptom scale, serum pepsinogen, operative link for gastritis assessment, operative link for gastric intestinal metaplasia assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yi LiangUniversity, hospital or other
- Collaborators
- Zhejiang University of Science and Technology
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
Brief Summary Template for the Study:
The goal of this observational study is to examine the relationship between digestive symptom scores, serum pepsinogen indices, and histopathological OLGA and OLGIM systematic staging of the gastric mucosa in patients with chronic atrophic gastritis(CAG), aiming to determine the degree of correlation between clinical manifestations, non-invasive laboratory tests, and the gold standard of diagnostic histopathology.To evaluate the comprehensive therapy, readiness and acceptance of acupuncture, utilization rates of various acupuncture therapies, self-assessed efficacy of acupuncture, and endoscopic histopathological alterations in patients with CAG.According to the aforementioned study, it is anticipated to enhance the optimization of acupuncture clinical research protocols for chronic atrophic gastritis, improve treatment efficacy, and offer more effective and rational therapy alternatives for patients.The main question it aims to answer is:
To determine if the outcomes of combined serologic testing of symptoms in patients with CAG can serve as a method for monitoring disease development and if long-term follow-up can be supported？
A group of participants with recorded GI symptom scores and blood pepsinogen levels will respond to online survey questions regarding the severity of their chronic atrophic gastritis progression over the course of 1 year.
Detailed description
This study is a multicenter cross-sectional pilot survey
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involved the recruitment of CAG patients from endoscopy centers, outpatient clinics, and inpatient clinics within the Department of Splenology and Gastroenterology at Zhongshan Hospital in Zhejiang Province, designated as the primary recruitment center, along with the First People's Hospital of Hangzhou and Hangzhou Hospital of Traditional Chinese Medicine as secondary recruitment centers.
Key inclusion criteria (3 listed)
- Fulfill the diagnostic criteria for chronic atrophic gastritis;
- Individuals aged 18 to 75 years, irrespective of gender;
- Capable of comprehending and consenting to participate in this study by signing the informed consent form.
Key exclusion criteria (4 listed)
- Autoimmune gastritis (type A chronic atrophic gastritis);
- Patients diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy or other examinations or patients diagnosed with high-grade intraepithelial neoplasia by upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
- Patients with confirmed or unable to exclude malignant tumors, especially esophageal and gastric cancers; patients with other upper gastrointestinal tract pathologies such as peptic ulcer or Barrett's esophagus;
- Those who cannot complete the questionnaire due to unconsciousness, inability to communicate normally or other reasons; those with incomplete information.
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 |
|---|---|---|
| acupunctureWhether or not a patient has been treated with acupuncture will be one of the exposure factors of interest in the study | Other | – |
Primary outcome
Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG
Time frame: Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment
The investigators gathered clinical data on the overall condition, occupation, personal history, family history, H. pylori infection, gastrointestinal symptom scores, serum pepsinogen index, gastroscopy reports, pathological findings, and other biological characteristics of CAG patients, along with data pertaining to acupuncture treatment. The investigators then analyzed the correlation between the gastrointestinal symptom scores, the serum pepsinogen index, and the gastric mucosal histopathology OLGA and OLGIM. The investigators examined the relationship between gastrointestinal symptom scores, serum pepsinogen levels, and the histopathological OLGA and OLGIM stages of gastric mucosa to determine the correlation between clinical manifestations, non-invasive laboratory tests, and the definitive diagnostic standard of histopathology, thereby offering support for clinicians.
1 secondary outcome
Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively
Time frame: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 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 2 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Atrophic Gastritis (CAG)
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Not yet recruitingObservational study
Association of Sleep Quality With Pathologic Staging, Acupuncture Treatment in Patients With Chronic Atrophic Gastritis: a Cross-sectional Study
Chronic Atrophic Gastritis (CAG)
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.
1 site 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 (CAG), run by Yi Liang at 1 site 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 3 inclusion and 4 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yi Liang, Doctor (+86 571 86633328, liangyiwww@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG (time frame: Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.