跳至主要内容
临床试验/NCT06084195
NCT06084195招募中不适用

Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging

Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年12月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer.

研究概览

简要总结

The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance

详细描述

After being informed about the study and potential risks, all patient giving wirtting informed consent.

During surgery, tissue and blood samples will be conserved for the study. In this study will be compared images obtained in vivo before surgical management, ex vivo images obtained on excised tissues during surgery, histological data obtained during surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patient aged >18
  • Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment
  • Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,
  • Patient who has given informed, written and express consent,
  • Patient affiliated with a French health insurance scheme.

排除标准

  • Early-stage disease (FIGO <IIIB) or presence of extraperitoneal metastases,
  • Patient who will not have surgery
  • Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
  • Patient under guardianship, curatorship or safeguarding of justice,
  • Pregnant and/or nursing patient,
  • Patient with a history of other cancers within 5 years/10 years prior to inclusion

研究组 & 干预措施

Single arm

Experimental

single arm

干预措施: Blood sample and tissue sample (Biological)

结局指标

主要结局

the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer.

时间窗: one shoot at the surgery

The diagnostic performance of the radiomic and multiomic algorithm for the characterization of heterogeneity in the CSOHG.

次要结局

  • the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale(one shoot at the surgery)
  • tumor heterogeneity based on phenotypic imaging supported by AI reflects and can predict sub-histologyunderlying by tumor stroma proportion and tumor density infiltrating lymphocytes and genomics through HRD(one shoot at the surgery)
  • the heterogeneity of the tumor biology of CSOHG through non-invasive habitat imaging combined with an integrated Multi-O-Mics approach.(one shoot at the surgery)
  • To Correlate MRI results with hematological molecular biology results.(one shoot at the surgery)

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (1)

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