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临床试验/NCT04844827
NCT04844827已完成不适用

Creation of a Pleural Carcinomatosis Tissue Bank

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2022年11月17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
143
试验地点
2
主要终点
Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)

研究概览

简要总结

Malignant pleural effusion is a common evolution of various cancers and is associated with poor prognosis and quality of life. About 28% of patients with primary malignancy will develop pleural metastasis. Malignant pleural effusion mostly occurs in lung, breast, ovarian and gastric cancers. Median survival ranges from 3 to 13 months according to primary malignancy. Currently, the therapeutic approach is mainly palliative with videothoracoscopic talc pleurodesis or indwelling pleural catheters insertion eventually associated with systemic chemotherapy if patient's general condition allows.

In a early-disseminated tumor cells profile, metastatic cells can accumulate alterations at a distant site and have a different profil from the original tumor cells. Metastatic cells can also accumulate alterations in the course if systemic treatments. Consequently, they may respond differently to drugs.

Recently, EGFR mutations and ALK status discordance between primary tumors and pleural metastases have been demonstrated in a significant portion of lung adenocarcinomas. These studies, realized on malignant pleural effusion isolated cells, enabled us to hypothesize a possible intratumoral heterogeneity within pleural metastases, but no study has been carried out on pleural tissue.

Our aim is to create a biocollection with tissues from pleural carcinomatosis in order to subsequently allow multiomics and bioinformatics analyzes and to characterize a possible intratumoral heterogeneity in pleural metastasis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female over 18 years old
  • Malignant pleural effusion with or without prior histological or cytological diagnosis
  • Patient eligible for a pleural biopsy for diagnostic purposes and validated in a multidisciplinary consultation meeting
  • Having given their free and informed writing consent
  • Affiliated to a social security system or assimilated

排除标准

  • Malignant pleural mesothelioma
  • Contraindication to general anesthesia
  • Pregnant or breastfeeding woman, or is of child bearing potential and who did not agree to use highly effective methods of birth control throughout the study.
  • Patient participating in a interventional study likely to interfere with this study
  • Patient benefiting from a legal protection measure (guardianship or curatorship)

结局指标

主要结局

Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)

时间窗: At Day 1: day of surgery

Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)

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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