Predicting lymph node status in early esophageal cancer
Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
This study is trying to find out if certain factors can help predict whether early esophageal cancer has spread to the lymph nodes, which could help doctors make better treatment decisions for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Renmin Hospital of Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05980403 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a prediction model for assessing lymph node metastasis in patients with superficial esophageal squamous cell carcinoma. By retrospectively analyzing clinical and pathological data from 300 patients, the researchers will identify risk factors associated with lymph node involvement. Additionally, they will prospectively collect tissue samples from 30 patients to investigate the mechanisms behind lymph node metastasis. The goal is to enhance clinical decision-making and improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with T1NxM0 esophageal squamous cell carcinoma who have undergone endoscopic resection or esophagectomy.
Not a fit: Patients who have received neoadjuvant therapy or have positive surgical margins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of lymph node involvement, helping to tailor treatment plans for patients with esophageal cancer.
How similar studies have performed: While there have been studies on lymph node status prediction, this specific approach focusing on superficial esophageal squamous cell carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Renmin hosptial of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Yongshun Chen, MD
- Email: yongshun2007@163.com
- Phone: +8615327122084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.