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Trial Title:
Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
NCT ID:
NCT05980403
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
superficial esophageal squamous cell carcinoma
lymph node metastasis
prediction model
tumor- infiltrating immune cells
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
no intervention
Description:
no intervention
Arm group label:
Lymph node metastasis positive
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.
Criteria for eligibility:
Study pop:
Patients with superficial esophageal squamous cell carcinoma who underwent endoscopic
therapy or esophagectomy.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renmin hosptial of Wuhan University
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Recruiting
Contact:
Last name:
Liwei Chen
Phone:
86+15671578311
Email:
wdrmiit@163.com
Start date:
July 18, 2023
Completion date:
September 18, 2024
Lead sponsor:
Agency:
Yongshun Chen
Agency class:
Other
Source:
Renmin Hospital of Wuhan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05980403
