Esophageal Squamous Cell CarcinomaNCT07605663
an AI-Driven Four-Tier Invasion Depth Classification for Early Esophageal Cancer
An observational study of Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The goal of this retrospective observational study is to evaluate whether preoperative endoscopic imaging can accurately assess tumor invasion depth in patients with early esophageal neoplasia undergoing endoscopic submucosal dissection (ESD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- ESD and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 890 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jun 2026
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients diagnosed with esophageal neoplasms and treated with endoscopic submucosal dissection (ESD) at 2 hospitals, the Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital (Shanghai and Xiamen), between the January, 2020 and January, 2026 were prospectively enrolled in this study.
Who may be able to join
- Pathologically confirmed EEC or high-grade intraepithelial neoplasia;
- Underwent ESD with complete postoperative pathological report;
- Preoperative high-quality WLI, NBl, iodine staining and BLI endoscopic images;
- complete clinical data.
Who cannot join
- Poor-quality endoscopic images;
- Previous esophageal surgery, neoadjuvant chemoradiotherapy, or other malignant tumors;
- Missing pathological invasion depth data;
- Synchronous distant metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this retrospective observational study is to evaluate whether preoperative endoscopic imaging can accurately assess tumor invasion depth in patients with early esophageal neoplasia undergoing endoscopic submucosal dissection (ESD).
The main question it aims to answer is:"How accurately can preoperative multimodal endoscopic imaging predict histopathological invasion depth in early esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia?" If there is a comparison group: Not applicable (no intervention or arm comparison was specified; analyses are based on diagnostic performance against postoperative pathology as the reference standard).
Read more
Participants will:
- Be retrospectively identified from two tertiary hospitals in China;
- Have pathologically confirmed early esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia treated with ESD;
- Have complete postoperative pathology data including invasion depth, lesion size, location, lymphovascular invasion, and margin status;
- Have preoperative high-quality endoscopic images (white-light imaging, narrow-band imaging, iodine staining, and blue laser imaging);
- Undergo retrospective image-pathology correlation analysis to assess diagnostic performance of invasion depth assessment.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- ESD, Surgery
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDProcedure or surgery
Endoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms. The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope. After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria. A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer. Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed. The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation. Post-resection inspection of the artificial ulcer is performed to assess for bleeding
SurgeryProcedure or surgery
Surgery after ESD
| Study group | Role | What they receive |
|---|---|---|
| ESD | Not described Receives: Procedure: ESD | |
| ESD+surgery | Not described Receives: Procedure: ESD; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pathological indications for additional surgery
According to current guidelines, non-curative resection requiring consideration of additional radical treatment was defined by the presence of submucosal invasion (SM2 invasion), or lymphovascular invasion (LVI-positive), or a positive vertical resection margin (VM-positive).
Measured: Week1
Actual receipt of additional surgery
Actual receipt of additional surgery was defined as patients who underwent subsequent radical surgical treatment after ESD based on multidisciplinary team (MDT) recommendations, clinician judgment, and patient preference.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jan 2020
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao, Pingting, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605663
- Sponsor's protocol ID
- B2025-145(2); B2025-134
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] FERLAY J, COLOMBET M, SOERJOMATARAM I, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J]. CA Cancer J Clin, 2021, 71(3): 209-49. [2] EUROPEAN SOCIETY OF GASTROINTESTINAL E. ESGE clinical guideline for the diagnosis and treatment of early esophageal cancer [J]. Endoscopy, 2023, 55(7): 649-67. [3] JAPANESE ESOPHAGEAL S. Japanese guidelines for the treatment of esophageal cancer 2022 edition [J]. Esophagus, 2022, 19(1): 1-124. [4] WANG Z, LI Y, ZHANG M, et al. Non-curative endoscopic submucosal dissection for early esophageal squamous cell carcinoma: risk factors and clinical outcomes [J]. J Gastroenterol Hepatol, 2023, 38(10): 1892-9.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- an AI-Driven Four-Tier Invasion Depth Classification for Early Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07605663
- Acronym / sponsor ID
- B2025-145(2); B2025-134
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 May 2026 (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 retrospective observational study is to evaluate whether preoperative endoscopic imaging can accurately assess tumor invasion depth in patients with early esophageal neoplasia undergoing endoscopic submucosal dissection (ESD).
The main question it aims to answer is:"How accurately can preoperative multimodal endoscopic imaging predict histopathological invasion depth in early esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia?" If there is a comparison group: Not applicable (no intervention or arm comparison was specified; analyses are based on diagnostic performance against postoperative pathology as the reference standard).
Participants will:
- Be retrospectively identified from two tertiary hospitals in China;
- Have pathologically confirmed early esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia treated with ESD;
- Have complete postoperative pathology data including invasion depth, lesion size, location, lymphovascular invasion, and margin status;
- Have preoperative high-quality endoscopic images (white-light imaging, narrow-band imaging, iodine staining, and blue laser imaging);
- Undergo retrospective image-pathology correlation analysis to assess diagnostic performance of invasion depth assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD | – | Procedure: ESD |
| ESD+surgery | – | Procedure: ESD, Procedure: Surgery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients diagnosed with esophageal neoplasms and treated with endoscopic submucosal dissection (ESD) at 2 hospitals, the Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital (Shanghai and Xiamen), between the January, 2020 and January, 2026 were prospectively enrolled in this study.
Key inclusion criteria (4 listed)
- Pathologically confirmed EEC or high-grade intraepithelial neoplasia;
- Underwent ESD with complete postoperative pathological report;
- Preoperative high-quality WLI, NBl, iodine staining and BLI endoscopic images;
- complete clinical data.
Key exclusion criteria (4 listed)
- Poor-quality endoscopic images;
- Previous esophageal surgery, neoadjuvant chemoradiotherapy, or other malignant tumors;
- Missing pathological invasion depth data;
- Synchronous distant metastasis.
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 |
|---|---|---|
| ESDEndoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms. The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope. After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria. A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer. Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed. The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation. Post-resection inspection of the artificial ulcer is performed to assess for bleeding | Procedure or surgery | ESD, ESD+surgery |
| SurgerySurgery after ESD | Procedure or surgery | ESD+surgery |
Primary outcome
Presence of pathological indications for additional surgery
Time frame: Week1
According to current guidelines, non-curative resection requiring consideration of additional radical treatment was defined by the presence of submucosal invasion (SM2 invasion), or lymphovascular invasion (LVI-positive), or a positive vertical resection margin (VM-positive).
Actual receipt of additional surgery
Time frame: Week 1
Actual receipt of additional surgery was defined as patients who underwent subsequent radical surgical treatment after ESD based on multidisciplinary team (MDT) recommendations, clinician judgment, and patient preference.
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 26 May 2026.
- Background[1] FERLAY J, COLOMBET M, SOERJOMATARAM I, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J]. CA Cancer J Clin, 2021, 71(3): 209-49. [2] EUROPEAN SOCIETY OF GASTROINTESTINAL E. ESGE clinical guideline for the diagnosis and treatment of early esophageal cancer [J]. Endoscopy, 2023, 55(7): 649-67. [3] JAPANESE ESOPHAGEAL S. Japanese guidelines for the treatment of esophageal cancer 2022 edition [J]. Esophagus, 2022, 19(1): 1-124. [4] WANG Z, LI Y, ZHANG M, et al. Non-curative endoscopic submucosal dissection for early esophageal squamous cell carcinoma: risk factors and clinical outcomes [J]. J Gastroenterol Hepatol, 2023, 38(10): 1892-9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Squamous Cell Carcinoma, run by Fudan University 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 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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?
Presence of pathological indications for additional surgery (time frame: Week1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605663, which also lists 1 linked publication.
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 26 May 2026.