Esophageal Cancer, Squamous CellNCT06984055
Diagnostic Accuracy of Endocytoscopy for Superficial Esophageal Neoplasia
An observational study of Esophageal Cancer, Squamous Cell, run by Changhai Hospital at 1 site in China.
Trial summary
In recent years, endocytoscopy (EC) has undergone rapid development as an advanced endoscopic technique. Characterized by real-time histological imaging and detection capabilities, EC enables visualization of living cells in the digestive mucosal layer through methylene blue staining via the endoscopic instrument… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer, Squamous Cell
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 1 Dec 2026
- How long will I take part?
- 1 Year
- 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 endocytoscopy due to related symptoms from April 2025 to December 2026
Who may be able to join
- 1.Patients diagnosed with superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) through endoscopic and pathological biopsy examinations, scheduled for endoscopic submucosal dissection (ESD); 2.Patients with esophageal squamous low-grade intraepithelial neoplasia (LGIN) confirmed by endoscopic and biopsy histopathological examinations within the preceding six months; 3. Patients exhibiting esophageal focal lesions detected during painless upper gastrointestinal endoscopy requiring pathological biopsy.
Who cannot join
- Patients aged <18 years or >80 years;
- Lesions located at the gastroesophageal junction with clinical suspicion of adenocarcinoma or precancerous lesions;
- Patients with contraindications to sedated/anesthetized upper gastrointestinal endoscopy;
- Patients with coagulation disorders;
- Patients with a history of hypersensitivity to relevant medications (including anesthetics or methylene blue);
- Patients presenting dysphagia or gastrointestinal obstructive symptoms, or those with suspected/confirmed digestive tract obstruction, stenosis, or fistulae;
- Patients declining to provide informed consent for study participation, or any other circumstances deemed by investigators to preclude eligibility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Accuracy of Deep Learning-Assisted Multimodal Endocytoscopy for Superficial Esophageal Neoplasia and Precancerous Lesions: A Multicenter ，Prospective Study
In recent years, endocytoscopy (EC) has undergone rapid development as an advanced endoscopic technique. Characterized by real-time histological imaging and detection capabilities, EC enables visualization of living cells in the digestive mucosal layer through methylene blue staining via the endoscopic instrument channel. This technology provides ultra-magnified endocytoscopic images, allowing for identification of key cellular features including epithelial cell morphology and the shape of methylene blue-stained epithelial nuclei, thereby facilitating clear in vivo observation of microstructural characteristics in mucosal tissues - a technique commonly referred to as "optical biopsy". However, current clinical application of EC in China remains limited due to insufficient practical experience and the absence of standardized diagnostic criteria for image interpretation. This study aims to comprehensively evaluate the diagnostic accuracy of domestically developed high-magnification electronic upper gastrointestinal endoscopy for esophageal carcinoma and precancerous lesions, using histopathology as the gold standard. The research objectives include establishing standardized diagnostic evaluation protocols and clarifying the clinical value of this technology through systematic validation.
- Conditions
- Esophageal Cancer, Squamous Cell
- Keywords
- Endocytoscopy, Esophageal Neoplasia, Precancerous Lesions, Deep Learning
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
sensitivity and specificity
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start11 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer, Squamous CellStudies 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
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, the Tenth People's Hospital affiliated to Tongji University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, The Second Hospital of Nanjing Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Principal investigator, Luowei Wang, MD, Changhai Hospital
- Investigators
- Wang Luowei, Principal investigator, Changhai hosipital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984055
- Sponsor's protocol ID
- DAESEN
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Deep Learning-Assisted Multimodal Endocytoscopy for Superficial Esophageal Neoplasia and Precancerous Lesions: A Multicenter ，Prospective Study
- ClinicalTrials.gov ID
- NCT06984055
- Acronym / sponsor ID
- DAESEN
- Conditions
- Esophageal Cancer, Squamous Cell
- Keywords
- Endocytoscopy, Esophageal Neoplasia, Precancerous Lesions, Deep Learning
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, the Tenth People's Hospital affiliated to Tongji University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, The Second Hospital of Nanjing Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 May 2025 (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.
In recent years, endocytoscopy (EC) has undergone rapid development as an advanced endoscopic technique. Characterized by real-time histological imaging and detection capabilities, EC enables visualization of living cells in the digestive mucosal layer through methylene blue staining via the endoscopic instrument channel. This technology provides ultra-magnified endocytoscopic images, allowing for identification of key cellular features including epithelial cell morphology and the shape of methylene blue-stained epithelial nuclei, thereby facilitating clear in vivo observation of microstructural characteristics in mucosal tissues - a technique commonly referred to as "optical biopsy". However, current clinical application of EC in China remains limited due to insufficient practical experience and the absence of standardized diagnostic criteria for image interpretation. This study aims to comprehensively evaluate the diagnostic accuracy of domestically developed high-magnification electronic upper gastrointestinal endoscopy for esophageal carcinoma and precancerous lesions, using histopathology as the gold standard. The research objectives include establishing standardized diagnostic evaluation protocols and clarifying the clinical value of this technology through systematic validation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population who underwent endocytoscopy due to related symptoms from April 2025 to December 2026
Key inclusion criteria (1 listed)
- 1.Patients diagnosed with superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) through endoscopic and pathological biopsy examinations, scheduled for endoscopic submucosal dissection (ESD); 2.Patients with esophageal squamous low-grade intraepithelial neoplasia (LGIN) confirmed by endoscopic and biopsy histopathological examinations within the preceding six months; 3. Patients exhibiting esophageal focal lesions detected during painless upper gastrointestinal endoscopy requiring pathological biopsy.
Key exclusion criteria (7 listed)
- Patients aged <18 years or >80 years;
- Lesions located at the gastroesophageal junction with clinical suspicion of adenocarcinoma or precancerous lesions;
- Patients with contraindications to sedated/anesthetized upper gastrointestinal endoscopy;
- Patients with coagulation disorders;
- Patients with a history of hypersensitivity to relevant medications (including anesthetics or methylene blue);
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
Diagnostic accuracy
Time frame: 10 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 22 May 2025.
- 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.
Wang Luowei principal investigator
Changhai hosipital, Shanghai
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 Cancer, Squamous Cell, 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 7 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: enrolling by invitation, as of the sponsor's last update on 22 May 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 10 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 22 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.