Esophageal Squamous Cell CarcinomaNCT05980403
Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
An observational study of Esophageal Squamous Cell Carcinoma, run by Yongshun Chen at 1 site in China.
Trial summary
Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2023to 18 Dec 2024
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with superficial esophageal squamous cell carcinoma who underwent endoscopic therapy or esophagectomy.
Who may be able to join
- Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022.
- Histopathological diagnosis was squamous cell carcinoma.
- T1NxM0.
- Received endoscopic resection or esophagectomy.
Who cannot join
- Patients who received neoadjuvant therapy.
- Positive surgical margin.
- Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured.
- Lack of complete histopathological information.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin hosptial of Wuhan University
Wuhan, Hubei, 430060
Liwei Chen, 86+15671578311, wdrmiit@163.com
About this study
Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. In this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. In addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- no intervention
- Keywords
- superficial esophageal squamous cell carcinoma, lymph node metastasis, prediction model, tumor- infiltrating immune cells
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Lymph node metastasis negative | Superficial esophageal squamous cell carcinoma with negative lymph node metastasis | |
| Lymph node metastasis positive | Superficial esophageal squamous cell carcinoma with positive lymph node metastasis Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic metastases
The primary end point was the presence of lymph node metastases in surgically resected specimens (≥ 15 resected lymph nodes), or the development of metastases during follow-up including local recurrence and distant metastasis (AJCC 8th). In cases of an endoscopic resection prior to surgical resection, the tumor was found in the endoscopic resection specimen and lymph node status in the surgical resection specimen. When no additional surgery was performed after endoscopic resection, the development of metastases during follow-up was used as a surrogate end point.
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start18 Jul 2023
- Primary completion18 Jan 2024
- Study completion18 Dec 2024 (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.
- 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Yongshun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongshun Chen, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980403
- Sponsor's protocol ID
- WDRY2023-K115
- Status last verified
- Jan 2024
- First submitted
- 21 Jul 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu H, Fan X, Liu C, Yan H, Luo X, Qiu H, Gong Y, Zhang C, Lu N, Yuan J, Xu X, Chen H, Chen Y. Immune Cellular Patterns Predicting Lymph Node Status Helps Personalized Management of Stage T1 Esophageal Squamous Cell Carcinoma. Mod Pathol. 2025 Oct;38(10):100814. doi: 10.1016/j.modpat.2025.100814. Epub 2025 Jun 12.
PubMed 40516607
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
- ClinicalTrials.gov ID
- NCT05980403
- Acronym / sponsor ID
- WDRY2023-K115
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- superficial esophageal squamous cell carcinoma, lymph node metastasis, prediction model, tumor- infiltrating immune cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yongshun ChenUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Dec 2024 (estimated)
- First posted
- 8 Aug 2023 (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.
Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. In this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. In addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymph node metastasis negative | – | –Superficial esophageal squamous cell carcinoma with negative lymph node metastasis |
| Lymph node metastasis positive | – | Other: no interventionSuperficial esophageal squamous cell carcinoma with positive lymph node metastasis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with superficial esophageal squamous cell carcinoma who underwent endoscopic therapy or esophagectomy.
Key inclusion criteria (4 listed)
- Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022.
- Histopathological diagnosis was squamous cell carcinoma.
- T1NxM0.
- Received endoscopic resection or esophagectomy.
Key exclusion criteria (4 listed)
- Patients who received neoadjuvant therapy.
- Positive surgical margin.
- Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured.
- Lack of complete histopathological information.
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 |
|---|---|---|
| no interventionno intervention | Other | Lymph node metastasis positive |
Primary outcome
Lymphatic metastases
Time frame: Through study completion, an average of 2 year
The primary end point was the presence of lymph node metastases in surgically resected specimens (≥ 15 resected lymph nodes), or the development of metastases during follow-up including local recurrence and distant metastasis (AJCC 8th). In cases of an endoscopic resection prior to surgical resection, the tumor was found in the endoscopic resection specimen and lymph node status in the surgical resection specimen. When no additional surgery was performed after endoscopic resection, the development of metastases during follow-up was used as a surrogate end point.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 40516607Zhu H, Fan X, Liu C, Yan H, Luo X, Qiu H, Gong Y, Zhang C, Lu N, Yuan J, Xu X, Chen H, Chen Y. Immune Cellular Patterns Predicting Lymph Node Status Helps Personalized Management of Stage T1 Esophageal Squamous Cell Carcinoma. Mod Pathol. 2025 Oct;38(10):100814. doi: 10.1016/j.modpat.2025.100814. Epub 2025 Jun 12.
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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.
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 Yongshun Chen 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: status not confirmed, as of the sponsor's last update on 14 Nov 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 Yongshun Chen, MD (+8615327122084, yongshun2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphatic metastases (time frame: Through study completion, an average of 2 year). 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 NCT05980403, 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 14 Nov 2024.