Gastric CancerEGC-FranceNCT05928819
Evaluation of a Computer-aided Diagnosis System (CADx) in the Early Detection of Gastric Cancer in France. Cancer in France.
An observational study of Gastric Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Upper gastrointestinal (GI) cancers are one of the most common cancers worldwide. Except for cardia cancers, the incidence of gastric cancer has decreased consistently since 1980, but remains at a high level. In France, gastric cancers are the 6th most common cause of cancer-related mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Every patient referred to our center for upper gastrointestinal endoscopy for investigation and/or resection of gastric neoplastic lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists.
Who may be able to join
- both gender patients even or older than 18 years old
- patient in need of proven diagnostic or therapeutic gastroscopy for gastric lesion resection
- patient with French Health Insurance coverage
- obtaining of oral non opposition to research after loyal, clear and complete delivery of information
Who cannot join
- previous attempt of lesion resection
- patient with no gastric lesion
- inadequate examination quality (gastroparesis)
- patient with health disorders needing short procedure times
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69437
Mathieu PIOCHE, MD, 04.72.11.01.45 ext. +33, mathieu.pioche@chu-lyon.fr
Laurent MAGAUD, CRA, 04 72 11 51 64 ext. +33, laurent.magaud@chu-lyon.fr
About this study
Official title: Early Detection of Gastric Cancer in France: Evaluation of the Diagnostic Capacity of a Computer-aided Diagnostic System (CADx) Compared to Endoscopists. EGC-France
Upper gastrointestinal (GI) cancers are one of the most common cancers worldwide. Except for cardia cancers, the incidence of gastric cancer has decreased consistently since 1980, but remains at a high level. In France, gastric cancers are the 6th most common cause of cancer-related mortality. The risk factors of upper GI cancers are well known and their control could prevent the development of cancers: smoking cessation, reduction of obesity, alcohol, eradication of Helicobacter pylori. But late presentation with upper GI cancer results in a poorer prognosis. Patients with advanced (Stage IV) gastric cancer have a five-year survival rate of 3.7% whereas patients whose gastric cancer is discovered in its early stage (Stage I) have a significantly higher five-year survival rate of 88.4%. Therefore, endoscopic detection of upper GI lesions at an earlier stage is the single most effective measure for reducing cancer mortality. But upper GI cancer is also often missed during examinations, and some studies demonstrated a missed cancer rate of 2.3-13.9% in Western populations. In the past decade, accurate diagnosis during endoscopy has become particularly important as dysplastic lesions and early gastric cancers can be treated effectively with both endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), avoiding the morbidity and mortality associated with gastrectomy. However, these early neoplastic lesions can be sometimes difficult to distinguish from background mucosa, even with advanced imaging techniques (high definition, chromoendoscopy).
In recent years, image recognition using artificial intelligence (AI) with deep learning has dramatically improved and opened the door to more detailed image analysis and real time application in various medical field, including endoscopy. For example, in the colorectal cancer screening area, real time computer-aided detection systems (CADe) can lead to significant increases in both polyp and adenoma detection rates.
Read more
CADe has also shown good performance in detection of Barrett's neoplasia during live endoscopic procedures in order to more accurately locate the area to be biopsied. Recently, a Chinese study showed that CADe achieved high diagnostic accuracy in detecting upper GI cancers, with sensitivity similar to that of expert endoscopists and superior to that of non-experts. This system could support non-experts by improving their diagnostic accuracy to a level similar to that of experts and provide assistance for improving the effectiveness of upper GI cancer diagnosis and screening.
Although encouraging results have been published regarding the use of AI in the diagnosis of upper GI cancers, the clinical applicability of such systems in a European population has yet to be investigated.
Therefore, we want to evaluate the diagnostic capability of a recent CADx compared to endoscopists in order to improve the real-time detection of early gastric cancers in our European center Edouard Herriot Hospital, Lyon, France, as well as 3 other tertiary centers in France (Limoges, Rennes and Nancy University Hospitals).
With a high prevalence of stomach cancer, Japan is a world leader in high-quality diagnostic upper GI endoscopy, and the clinical routine in this country differs substantially from Western practice, with population-based screening programs. We will use for our study a CADx developed by AI medical service Inc. (1-18-1, Higashiikebukuro, Toshima-ku, Tokyo 170-0013, Japan), a Japanese company developing AI systems that supports endoscopist's diagnosis for the digestive tract. A recent study involving AI medical service system showed good results in the diagnosis of early gastric cancer compared to endoscopists, with a significantly higher sensitivity.
- Conditions
- Gastric Cancer
- Being tested
- Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.
- Keywords
- diagnostic tool, AI, CAD, gastric cancer, therapeutic choice guidance
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.Procedure or surgery
Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.
| Study group | Role | What they receive |
|---|---|---|
| Gastric lesion diagnostic | Every patient referred to our center for upper gastrointestinal endoscopy for investigation and/or resection of gastric neoplastic lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists. Receives: Procedure: Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists and correlation with final histology reading.
Measured: Time point can be reached either 2 weeks after endoscopic resection at first visit or between 2-4 months later in case of surgery at third visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928819
- Sponsor's protocol ID
- 658
- Other IDs
- 69HCL21_1313
- Acronym
- EGC-France
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Gastric Cancer in France: Evaluation of the Diagnostic Capacity of a Computer-aided Diagnostic System (CADx) Compared to Endoscopists. EGC-France
- ClinicalTrials.gov ID
- NCT05928819
- Acronym / sponsor ID
- EGC-France / 658
- Conditions
- Gastric Cancer
- Keywords
- diagnostic tool, AI, CAD, gastric cancer, therapeutic choice guidance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
Upper gastrointestinal (GI) cancers are one of the most common cancers worldwide. Except for cardia cancers, the incidence of gastric cancer has decreased consistently since 1980, but remains at a high level. In France, gastric cancers are the 6th most common cause of cancer-related mortality. The risk factors of upper GI cancers are well known and their control could prevent the development of cancers: smoking cessation, reduction of obesity, alcohol, eradication of Helicobacter pylori. But late presentation with upper GI cancer results in a poorer prognosis. Patients with advanced (Stage IV) gastric cancer have a five-year survival rate of 3.7% whereas patients whose gastric cancer is discovered in its early stage (Stage I) have a significantly higher five-year survival rate of 88.4%. Therefore, endoscopic detection of upper GI lesions at an earlier stage is the single most effective measure for reducing cancer mortality. But upper GI cancer is also often missed during examinations, and some studies demonstrated a missed cancer rate of 2.3-13.9% in Western populations. In the past decade, accurate diagnosis during endoscopy has become particularly important as dysplastic lesions and early gastric cancers can be treated effectively with both endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), avoiding the morbidity and mortality associated with gastrectomy. However, these early neoplastic lesions can be sometimes difficult to distinguish from background mucosa, even with advanced imaging techniques (high definition, chromoendoscopy).
In recent years, image recognition using artificial intelligence (AI) with deep learning has dramatically improved and opened the door to more detailed image analysis and real time application in various medical field, including endoscopy. For example, in the colorectal cancer screening area, real time computer-aided detection systems (CADe) can lead to significant increases in both polyp and adenoma detection rates.
CADe has also shown good performance in detection of Barrett's neoplasia during live endoscopic procedures in order to more accurately locate the area to be biopsied. Recently, a Chinese study showed that CADe achieved high diagnostic accuracy in detecting upper GI cancers, with sensitivity similar to that of expert endoscopists and superior to that of non-experts. This system could support non-experts by improving their diagnostic accuracy to a level similar to that of experts and provide assistance for improving the effectiveness of upper GI cancer diagnosis and screening.
Although encouraging results have been published regarding the use of AI in the diagnosis of upper GI cancers, the clinical applicability of such systems in a European population has yet to be investigated.
Therefore, we want to evaluate the diagnostic capability of a recent CADx compared to endoscopists in order to improve the real-time detection of early gastric cancers in our European center Edouard Herriot Hospital, Lyon, France, as well as 3 other tertiary centers in France (Limoges, Rennes and Nancy University Hospitals).
With a high prevalence of stomach cancer, Japan is a world leader in high-quality diagnostic upper GI endoscopy, and the clinical routine in this country differs substantially from Western practice, with population-based screening programs. We will use for our study a CADx developed by AI medical service Inc. (1-18-1, Higashiikebukuro, Toshima-ku, Tokyo 170-0013, Japan), a Japanese company developing AI systems that supports endoscopist's diagnosis for the digestive tract. A recent study involving AI medical service system showed good results in the diagnosis of early gastric cancer compared to endoscopists, with a significantly higher sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric lesion diagnostic | – | Procedure: Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.Every patient referred to our center for upper gastrointestinal endoscopy for investigation and/or resection of gastric neoplastic lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Every patient referred to our center for upper gastrointestinal endoscopy for investigation and/or resection of gastric neoplastic lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists.
Key inclusion criteria (4 listed)
- both gender patients even or older than 18 years old
- patient in need of proven diagnostic or therapeutic gastroscopy for gastric lesion resection
- patient with French Health Insurance coverage
- obtaining of oral non opposition to research after loyal, clear and complete delivery of information
Key exclusion criteria (4 listed)
- previous attempt of lesion resection
- patient with no gastric lesion
- inadequate examination quality (gastroparesis)
- patient with health disorders needing short procedure times
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 |
|---|---|---|
| Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists.Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists. | Procedure or surgery | Gastric lesion diagnostic |
Primary outcome
Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists and correlation with final histology reading.
Time frame: Time point can be reached either 2 weeks after endoscopic resection at first visit or between 2-4 months later in case of surgery at third visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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. This study is not recruiting at the moment.
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 Gastric Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre LAFEUILLE, MD (33472110143, pierre.lafeuille@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the proportion of gastric neoplastic lesions detected by a computer-aided diagnosis system (CADx) compared with experienced endoscopists and correlation with final histology reading. (time frame: Time point can be reached either 2 weeks after endoscopic resection at first visit or between 2-4 months later in case of surgery at third visit). 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 3 Jul 2023.