跳至主要内容
临床试验/NCT06366906
NCT06366906已完成不适用

Clinicopathological and Prognostic Analysis of Oral and Maxillofacial Squamous Cell Carcinoma: a Single-center 10-year Retrospective Study

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University2 个研究点 分布在 1 个国家目标入组 319 人开始时间: 2023年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
319
试验地点
2
主要终点
AUC(the area under the curve) values of the model

研究概览

简要总结

Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.

Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.

Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Pathologically confirmed, previously untreated oral and oropharyngeal squamous cell carcinoma with radical resection;
  • MRI examination was performed two weeks before surgery;
  • All patients with neck dissection and the status of regional lymph nodes was confirmed via pathological examination;
  • All patients had no clinical evidence of nodal involvement.

排除标准

  • Other malignant tumor, such as adenoid cystic carcinoma;
  • a lack of complete MRI imaging or poor MRI imaging quality;
  • patients had undergone neck dissection or treated non-surgically;
  • patients with metastatic disease.

结局指标

主要结局

AUC(the area under the curve) values of the model

时间窗: 10 years(This is a retrospective research,we collect 10 years patients, but the project we implement data collection and analysis is 9 months)

The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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