跳至主要内容
临床试验/NCT06533709
NCT06533709招募中不适用

Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data and Its Clinical Application

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
146
试验地点
1
主要终点
R0 resection

研究概览

简要总结

This project intends to conduct a multicenter retrospective study to evaluate the satisfactory reduction of advanced ovarian cancer using PET-CT images, and explore the correlation between molecular biological characteristics and clinical characteristics of ovarian cancer through high-throughput sequencing genomics combined with radiomics.

详细描述

Ovarian cancer is the gynecological malignant tumor with the highest fatality rate. More than 70% of patients are diagnosed with advanced stage, often involving various organs of the pelvis and abdomen, which increases the difficulty of surgical resection, and the 5-year survival rate is only 30%. Surgical treatment is the cornerstone of the treatment of ovarian cancer, and whether it can achieve satisfactory tumor reduction is an important factor affecting the prognosis of ovarian cancer. At present, the methods used to evaluate whether satisfactory tumor reduction can be achieved include Suidan score based on CT image and Fagotti score based on laparoscopic exploration, but there are problems such as low sensitivity, poor specificity or strong subjectivity, and the efficiency of predicting satisfactory tumor reduction is only about 60%. In recent years, PET-CT has been widely used in tumor diagnosis. Pet-ct combined with PET metabolic imaging technology and traditional CT scanning can help to distinguish the nature of tumors, assess the systemic tumor load, define the scope of the lesion, and provide the metabolic status of various parts of the body. The application value of PET-CT related imaging features and metabolic information in ovarian cancer needs to be clarified. Our team's previous study found that PET-CT related images and metabolic information showed certain advantages in predicting satisfactory resection of ovarian cancer, and the AUC reached 0.85, which was better than the current CT image score and laparoscopic score. Therefore, this project intends to conduct a multicenter retrospective study to evaluate the satisfactory tumor reduction rate of advanced ovarian cancer using PET-CT images to guide clinical practice and predict the prognosis of patients. At the same time, we will explore the molecular biological characteristics and clinical relevance of ovarian cancer through the combination of high-throughput sequencing genomics and radiomics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pathological type is epithelial ovarian cancer.
  • Underwent primary debulking surgery at our hospital.
  • Postoperative pathological staging is FIGO stage IIB or above.
  • Clinical, surgical, and pathological data of the patient are mostly complete.

排除标准

  • Pathological type is non-epithelial ovarian cancer.
  • Underwent fertility-preserving surgery or palliative surgery.
  • Presence of infection during PET/CT image acquisition.
  • Concurrent other malignant tumors.
  • Severe diseases of other major organs.

结局指标

主要结局

R0 resection

时间窗: yes or not

In patients with advanced ovarian cancer, the residual status after initial cytoreductive surgery is defined as follows: complete resection is defined as R0 resection, whereas visible residual tumor lesions during surgery are defined as non-R0 resection

次要结局

  • Response to platinum-based chemotherapy(At least 6 months after the last chemotherapy)
  • 5-year progression-free survival (PFS)(5 years)
  • 5-year overall survival (OS)(5-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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