Gastroesophageal Reflux DiseaseGERDTNCT06504134
Gastroesophageal Reflux Disease Diagnostic Trial
An observational study of Gastroesophageal Reflux Disease, run by Changhai Hospital.
Trial summary
Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- the Novel Esophageal Cell Collection Device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2024to 31 Dec 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population who underwent testing with the novel esophageal cell collection device due to related symptoms from June 2024 to December 2027
Who may be able to join
- ≥18 years and ≤85 years, male or female;
- A visit was made for symptoms such as persistent reflux, heartburn, bloating, early satiety, and belching;
- Patients volunteered to participate in the clinical trial, signed an informed consent form, and were able to cooperate with clinical follow-up.
Who cannot join
- History of esophageal surgery;
- Presence of dysphagia, esophagogastric fundal varices, or esophageal stenosis;
- Presence of coagulation disorders or taking anticoagulant or antiplatelet drugs;
- Those with a life expectancy of less than 5 years;
- Persons with mental anomalies who are incapable of behavioral autonomy;
- Other conditions that, in the judgment of the physician, preclude participation in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. However, such examination is under a quite low acceptability. As a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. Our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. This project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of GRED, using the novel esophageal cell enrichment technology. The research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-AI interaction; 3) establishing a prediction model for GERD by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of GERD and its diagnostic value based on the enriched inflammatory cells. The ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of GERD.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- the Novel Esophageal Cell Collection Device
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Novel Esophageal Cell Collection DeviceDiagnostic test
Using the novel cell collection device and the deep learning method to collect and classify esophogeal cell to identify if the participants are GERD patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
sensitivity and specificity
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Ruijin Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Tongji Hospital, Tongji University School of Medicine, The Second Affiliated Hospital of Baotou Medical College
- Responsible party
- Principal investigator, Luowei Wang, MD, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504134
- Sponsor's protocol ID
- GERDT
- Acronym
- GERDT
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophageal Reflux Disease Diagnostic Trial
- ClinicalTrials.gov ID
- NCT06504134
- Acronym / sponsor ID
- GERDT / GERDT
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, Ruijin Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Tongji Hospital, Tongji University School of Medicine, The Second Affiliated Hospital of Baotou Medical College
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 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.
Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. However, such examination is under a quite low acceptability. As a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. Our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. This project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of GRED, using the novel esophageal cell enrichment technology. The research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-AI interaction; 3) establishing a prediction model for GERD by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of GERD and its diagnostic value based on the enriched inflammatory cells. The ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of GERD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population who underwent testing with the novel esophageal cell collection device due to related symptoms from June 2024 to December 2027
Key inclusion criteria (3 listed)
- ≥18 years and ≤85 years, male or female;
- A visit was made for symptoms such as persistent reflux, heartburn, bloating, early satiety, and belching;
- Patients volunteered to participate in the clinical trial, signed an informed consent form, and were able to cooperate with clinical follow-up.
Key exclusion criteria (6 listed)
- History of esophageal surgery;
- Presence of dysphagia, esophagogastric fundal varices, or esophageal stenosis;
- Presence of coagulation disorders or taking anticoagulant or antiplatelet drugs;
- Those with a life expectancy of less than 5 years;
- Persons with mental anomalies who are incapable of behavioral autonomy;
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 |
|---|---|---|
| the Novel Esophageal Cell Collection DeviceUsing the novel cell collection device and the deep learning method to collect and classify esophogeal cell to identify if the participants are GERD patients | Diagnostic test | – |
Primary outcome
Diagnostic accuracy
Time frame: 60 minutes
sensitivity and specificity
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 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by Changhai Hospital.
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 6 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 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Luowei Wang, MD (13901833088, wangluoweimd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 60 minutes). 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 16 Jul 2024.