Esophageal Neoplasms MalignantNCT06412419
Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Neoplasms Malignant, run by Changhai Hospital at 1 site in China.
Trial summary
The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms Malignant
- What is being tested?
- Magnifying Endoscopy and Endoscopic Ultrasonography
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 30 Oct 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: The study was conducted in two phases. The initial stage was the modeling stage (the first stage), which included patients from six hospitals including the First Affiliated Hospital of Naval Medical University before January 1, 2024. The second phase, called real-world evaluation phase (phase 2), prospectively enrolled consecutive patients scheduled to undergo magnifying endoscopy and EUS at the aforementioned hospitals between April and June 2024.
Who may be able to join
- Patients requiring magnifying endoscopy and endoscopic ultrasonography. Individuals of either sex, aged 18 years or older.
Who cannot join
- Inability to complete esophageal electronic endoscopy. Absence of biopsy or surgery, resulting in unobtainable pathological results. Patients who have undergone endoscopic lesion destruction or piecemeal resection, preventing the acquisition of an en bloc resection sample.
- Patients with significant endoscopic, imaging, or pathological evidence of advanced esophageal cancer.
- Patients presenting with marked esophageal stenosis or dilatation. Individuals with a history of other malignancies. Patients who have received neoadjuvant radiotherapy. Patients who declined to participate in the study and did not provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Based on Multimodal Endoscopy and Weakly Supervised Deep Learning-Early Esophageal Squamous Cell Carcinoma Infiltration Depth Precise Prediction Study
The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer.
The project's primary goals are to develop three distinct AI-assisted diagnostic systems:
Read more
An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions.
An AI-based EUS diagnostic system capable of automatically delineating the affected areas.
A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.
Read the detailed description
The study was executed in two distinct phases. The initial phase, designated as the modeling phase (Phase 1), involved a retrospective analysis of eligible subjects from a consortium of medical institutions, including the First Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Provincial Hospital Affiliated to Shandong First Medical University, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Henan University of Science and Technology, and the First Affiliated Hospital of Shihezi University, all selected prior to January 1, 2024. The second phase, known as the real-world evaluation phase (Phase 2), prospectively enrolled consecutive patients who were scheduled to undergo magnometric endoscopy and EUS at the aforementioned hospitals between April 2024 and June 2024.
- Conditions
- Esophageal Neoplasms Malignant
- Being tested
- Magnifying Endoscopy and Endoscopic Ultrasonography
- Keywords
- Esophageal Neoplasms, multimodality, Endosonography
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnifying Endoscopy and Endoscopic UltrasonographyDiagnostic test
The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.
| Study group | Role | What they receive |
|---|---|---|
| Low-grade intraepithelial neoplasia of esophageal squamous epithelium | Not described Receives: Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography | |
| High-grade intraepithelial neoplasia of esophageal squamous epithelium | Not described Receives: Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography | |
| Stage T1a esophageal squamous cell carcinoma | Not described Receives: Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography | |
| Stage T1b esophageal squamous cell carcinoma | Not described Receives: Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of models to diagnose low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and superficial esophageal squamous carcinoma
Endoscopic Submucosal Dissection (ESD) serving as the gold standard. Computation of sensitivity and specificity involves the use of four fundamental metrics: true positive (TP), true negative (TN), false negative (FN), and false positive (FP). Subsequently, the Area Under the Curve (AUC) is utilized to assess the diagnostic efficacy of the model.
Measured: 2024.04.01-2024.10.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 May 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Neoplasms MalignantStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Henan University of Science and Technology, The First Affiliated Hospital of Shihezi University
- Responsible party
- Sponsor
- Investigators
- Luowei Wang, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412419
- Sponsor's protocol ID
- MEIFI-sESCC
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 14 May 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on Multimodal Endoscopy and Weakly Supervised Deep Learning-Early Esophageal Squamous Cell Carcinoma Infiltration Depth Precise Prediction Study
- ClinicalTrials.gov ID
- NCT06412419
- Acronym / sponsor ID
- MEIFI-sESCC
- Conditions
- Esophageal Neoplasms Malignant
- Keywords
- Esophageal Neoplasms, multimodality, Endosonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Henan University of Science and Technology, The First Affiliated Hospital of Shihezi University
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 14 May 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.
The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer.
The project's primary goals are to develop three distinct AI-assisted diagnostic systems:
An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions.
An AI-based EUS diagnostic system capable of automatically delineating the affected areas.
A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.
Detailed description
The study was executed in two distinct phases. The initial phase, designated as the modeling phase (Phase 1), involved a retrospective analysis of eligible subjects from a consortium of medical institutions, including the First Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Provincial Hospital Affiliated to Shandong First Medical University, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Henan University of Science and Technology, and the First Affiliated Hospital of Shihezi University, all selected prior to January 1, 2024. The second phase, known as the real-world evaluation phase (Phase 2), prospectively enrolled consecutive patients who were scheduled to undergo magnometric endoscopy and EUS at the aforementioned hospitals between April 2024 and June 2024.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-grade intraepithelial neoplasia of esophageal squamous epithelium | – | Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography |
| High-grade intraepithelial neoplasia of esophageal squamous epithelium | – | Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography |
| Stage T1a esophageal squamous cell carcinoma | – | Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography |
| Stage T1b esophageal squamous cell carcinoma | – | Diagnostic Test: Magnifying Endoscopy and Endoscopic Ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in two phases. The initial stage was the modeling stage (the first stage), which included patients from six hospitals including the First Affiliated Hospital of Naval Medical University before January 1, 2024. The second phase, called real-world evaluation phase (phase 2), prospectively enrolled consecutive patients scheduled to undergo magnifying endoscopy and EUS at the aforementioned hospitals between April and June 2024.
Key inclusion criteria (1 listed)
- Patients requiring magnifying endoscopy and endoscopic ultrasonography. Individuals of either sex, aged 18 years or older.
Key exclusion criteria (3 listed)
- Inability to complete esophageal electronic endoscopy. Absence of biopsy or surgery, resulting in unobtainable pathological results. Patients who have undergone endoscopic lesion destruction or piecemeal resection, preventing the acquisition of an en bloc resection sample.
- Patients with significant endoscopic, imaging, or pathological evidence of advanced esophageal cancer.
- Patients presenting with marked esophageal stenosis or dilatation. Individuals with a history of other malignancies. Patients who have received neoadjuvant radiotherapy. Patients who declined to participate in the study and did not provide informed consent.
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 |
|---|---|---|
| Magnifying Endoscopy and Endoscopic UltrasonographyThe acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping. | Diagnostic test | High-grade intraepithelial neoplasia of esophageal squamous epithelium, Low-grade intraepithelial neoplasia of esophageal squamous epithelium, Stage T1a esophageal squamous cell carcinoma, Stage T1b esophageal squamous cell carcinoma |
Primary outcome
Performance of models to diagnose low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and superficial esophageal squamous carcinoma
Time frame: 2024.04.01-2024.10.30
Endoscopic Submucosal Dissection (ESD) serving as the gold standard. Computation of sensitivity and specificity involves the use of four fundamental metrics: true positive (TP), true negative (TN), false negative (FN), and false positive (FP). Subsequently, the Area Under the Curve (AUC) is utilized to assess the diagnostic efficacy of the model.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 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. This study is not recruiting at the moment.
Luowei Wang study chair
Changhai Hospital
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 Esophageal Neoplasms Malignant, run by Changhai Hospital 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 1 inclusion and 3 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 14 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luowei Wang (86-21-31161337, wangluoweimd@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of models to diagnose low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and superficial esophageal squamous carcinoma (time frame: 2024.04.01-2024.10.30). 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 14 May 2024.