Esophageal Squamous Cell CarcinomaNCT06252974
Accurate Diagnosis of the Invasion Depth in ESCC by a Deep Neural Network Analysis of NBI Endoscopy Data
An observational study of Esophageal Squamous Cell Carcinoma, run by RenJi Hospital.
Trial summary
The goal of this observational study is to accurate diagnose the stage of esophageal squamous cell carcinoma in order to help physicians to decide the appropriate clinical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2024to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: Around 500 cases.
Who may be able to join
- Age ≥ 18 years old, regardless of gender;
- Performing esophageal ESD surgery due to esophageal mucosal lesions;
- Pathological evaluation of ESD specimens.
Who cannot join
- Pathological examination after ESD surgery ruled out esophageal squamous cell carcinoma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accurate Diagnosis of the Invasion Depth in Early Esophageal Squamous Cell Carcinoma by a Deep Neural Network Analysis of Narrow-band Imaging Endoscopy Data
The goal of this observational study is to accurate diagnose the stage of esophageal squamous cell carcinoma in order to help physicians to decide the appropriate clinical treatment. The main question it aims to answer is:
- To get early accurate diagnosis of the invasion depth of esophageal squamous cell carcinoma by narrow-band imaging endoscopy data.
Participants' clinical informations from routine examinations and treatments will be collected, there will be no harm to participants.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate diagnose the invasion depth of early esophageal squamous cell carcinoma by endoscopy NBI images through deep neural network analysis
We will compare the predictive performance of InvaDepNet before and after incorporating data generated using GAN and demonstrated that including the generated data in the training dataset effectively improves the accuracy of the predictive model. Additionally, we will train six commonly used CNN models on two datasets with different shooting angles (including NBI without magnifying and NBI with magnifying), and we will propose a ResNet model to analysis the clinical informations combine with NBI images.
Measured: 2024/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start25 Apr 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252974
- Sponsor's protocol ID
- LY2023-229-B
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2024
- Last updated
- 29 Apr 2024
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Diagnosis of the Invasion Depth in Early Esophageal Squamous Cell Carcinoma by a Deep Neural Network Analysis of Narrow-band Imaging Endoscopy Data
- ClinicalTrials.gov ID
- NCT06252974
- Acronym / sponsor ID
- LY2023-229-B
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Feb 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 goal of this observational study is to accurate diagnose the stage of esophageal squamous cell carcinoma in order to help physicians to decide the appropriate clinical treatment. The main question it aims to answer is:
- To get early accurate diagnosis of the invasion depth of esophageal squamous cell carcinoma by narrow-band imaging endoscopy data.
Participants' clinical informations from routine examinations and treatments will be collected, there will be no harm to participants.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Around 500 cases.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old, regardless of gender;
- Performing esophageal ESD surgery due to esophageal mucosal lesions;
- Pathological evaluation of ESD specimens.
Key exclusion criteria (1 listed)
- Pathological examination after ESD surgery ruled out esophageal squamous cell carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accurate diagnose the invasion depth of early esophageal squamous cell carcinoma by endoscopy NBI images through deep neural network analysis
Time frame: 2024/12/31
We will compare the predictive performance of InvaDepNet before and after incorporating data generated using GAN and demonstrated that including the generated data in the training dataset effectively improves the accuracy of the predictive model. Additionally, we will train six commonly used CNN models on two datasets with different shooting angles (including NBI without magnifying and NBI with magnifying), and we will propose a ResNet model to analysis the clinical informations combine with NBI images.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by RenJi 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 1 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 29 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Ding, Doctor (+8613585966417, dr_daisy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate diagnose the invasion depth of early esophageal squamous cell carcinoma by endoscopy NBI images through deep neural network analysis (time frame: 2024/12/31). 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 29 Apr 2024.