Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237） (NCT05980403) | Clinical Trial Compass
UnknownNot Applicable
Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
China300 participantsStarted 2023-07-18
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lymphatic metastases
Timeframe: Through study completion, an average of 2 year