Esophageal Squamous Cell Cancer (SCC)NCT07074535
CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer
An observational study of Esophageal Squamous Cell Cancer (SCC) and Recurrent Laryngeal Nerve Palsy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The goal of this observational study is to develop a predictive model for left recurrent laryngeal nerve (RLN) lymph node metastasis using deep learning algorithms. The model will be developed using clinical data from previous esophageal cancer surgeries, including preoperative CT imaging, and histopathological images… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Cancer (SCC), Recurrent Laryngeal Nerve Palsy, Deep Learning
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2027
- How long will I take part?
- 6 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included were all esophageal cancer patients who received surgery and standard lymph node dissection in our hospital.
Who may be able to join
- Preoperative gastroscopic biopsy confirmed esophageal squamous cell carcinoma；
- The patient underwent esophagectomy with lymph nodes dissection along the left recurrent laryngeal nerve.
Who cannot join
- The patient's medical records are incomplete；
- The patient refused to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to develop a predictive model for left recurrent laryngeal nerve (RLN) lymph node metastasis using deep learning algorithms. The model will be developed using clinical data from previous esophageal cancer surgeries, including preoperative CT imaging, and histopathological images from gastroscopic biopsies. The model will also be validated through prospective clinical trials to guide the intraoperative lymph node dissection, thereby reducing postoperative risks of RLN injury.
- Conditions
- Esophageal Squamous Cell Cancer (SCC), Recurrent Laryngeal Nerve Palsy, Deep Learning, Postoperative Complication
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Vocal Cord Paralysis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Left RLN lymph node （+） | Postoperative pathological results confirmed the metastasis of left recurrent laryngeal nerve lymph nodes. | |
| Left RLN lymph node （-） | Postoperative pathological results confirmed the negative of left recurrent laryngeal nerve lymph nodes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC (Area Under the Receiver Operating Characteristic Curve)
The discriminant ability of the comprehensive evaluation model at different thresholds (positive vs. negative)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jan 2019
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2027 (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 Cancer (SCC)Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074535
- Sponsor's protocol ID
- CEDREL-LNM
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Datasets and codes for the study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07074535
- Acronym / sponsor ID
- CEDREL-LNM
- Conditions
- Esophageal Squamous Cell Cancer (SCC), Recurrent Laryngeal Nerve Palsy, Deep Learning, Postoperative Complication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Jul 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.
The goal of this observational study is to develop a predictive model for left recurrent laryngeal nerve (RLN) lymph node metastasis using deep learning algorithms. The model will be developed using clinical data from previous esophageal cancer surgeries, including preoperative CT imaging, and histopathological images from gastroscopic biopsies. The model will also be validated through prospective clinical trials to guide the intraoperative lymph node dissection, thereby reducing postoperative risks of RLN injury.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left RLN lymph node （+） | – | –Postoperative pathological results confirmed the metastasis of left recurrent laryngeal nerve lymph nodes. |
| Left RLN lymph node （-） | – | –Postoperative pathological results confirmed the negative of left recurrent laryngeal nerve lymph nodes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included were all esophageal cancer patients who received surgery and standard lymph node dissection in our hospital.
Key inclusion criteria (2 listed)
- Preoperative gastroscopic biopsy confirmed esophageal squamous cell carcinoma；
- The patient underwent esophagectomy with lymph nodes dissection along the left recurrent laryngeal nerve.
Key exclusion criteria (2 listed)
- The patient's medical records are incomplete；
- The patient refused to participate in the trial.
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
AUROC (Area Under the Receiver Operating Characteristic Curve)
Time frame: From enrollment to the end of treatment at 4 weeks
The discriminant ability of the comprehensive evaluation model at different thresholds (positive vs. negative)
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 20 Jul 2025.
- Individual participant dataSharing planned: Undecided. Datasets and codes for the study are available from the corresponding author on reasonable request.
Related trials for Esophageal Squamous Cell Cancer (SCC)
RecruitingPhase 1/2
A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
RecruitingPhase 3
Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer, Advanced Head and Neck Squamous Cell Carcinoma
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 Cancer (SCC) and Recurrent Laryngeal Nerve Palsy, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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 2 inclusion and 2 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 20 Jul 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?
AUROC (Area Under the Receiver Operating Characteristic Curve) (time frame: From enrollment to the end of treatment at 4 weeks). 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 20 Jul 2025.