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临床试验/NCT03488901
NCT03488901Unknown不适用

Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
72
试验地点
1
主要终点
Transcription profile associated with the resistance to chemotherapy

研究概览

简要总结

Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.

The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .

To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.

The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.

The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • confirmed gestational trophoblastic tumor histology
  • hCG follow-up of at least 12 months after hCG normalization
  • registration in the French Reference Center for Trophoblastic Diseases

排除标准

  • tissue specimen (block/biopsy) not available
  • degraded quality of tissue sample not compatible with transcriptome analysis (>20% of necrosis)

结局指标

主要结局

Transcription profile associated with the resistance to chemotherapy

时间窗: 10 months

The expression level of 800 genes involved in oncogenesis canonical pathways and immune tolerance will be assessed and correlated with the resistance to single or multiagent chemotherapy.

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 (1)

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