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Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma(RENMIN-237)

Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma(RENMIN-237)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05980403
Enrollment
300
Registered
2023-08-08
Start date
2023-07-18
Completion date
2024-12-18
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

superficial esophageal squamous cell carcinoma, lymph node metastasis, prediction model, tumor- infiltrating immune cells

Brief 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 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.

Interventions

OTHERno intervention

no intervention

Sponsors

Yongshun Chen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022. 2. Histopathological diagnosis was squamous cell carcinoma. 3. T1NxM0. 4. Received endoscopic resection or esophagectomy.

Exclusion criteria

1. Patients who received neoadjuvant therapy. 2. Positive surgical margin. 3. Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured. 4. Lack of complete histopathological information.

Design outcomes

Primary

MeasureTime frameDescription
Lymphatic metastasesThrough study completion, an average of 2 yearThe 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.

Countries

China

Contacts

Primary ContactYongshun Chen, MD
yongshun2007@163.com+8615327122084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026