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临床试验/NCT05146505
NCT05146505Unknown不适用

Analysis of Circulating miRNAs as Potential Biomarkers of Diagnosis and Prognosis in High Grade Serous Ovarian Cancer

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Longitudinal miRNAs analysis over chemotherapy

研究概览

简要总结

High grade serous ovarian cancer represents the gynecological malignancy with the highest incidence of mortality. Decision-making tools are currently limited to the use of standard imaging modalities and analysis of serum biomarkers, such as CA 125, which often have low specificity and sensitivity. Recently, a growing research interest has been aimed at so-called circulating microRNAs (miRNAs). Indeed, it has been observed that miRNAs are abundantly present in all biological fluids and play the key role of messengers in intercellular communication. Cancer cells have a rapid turnover which results in a continuous release of nucleic acids and vesicles derived from the tumor itself, such as the tumor cells themselves that separate from the tumor mass to enter the bloodstream. Given their important role as modulators of gene expression, in order to preserve their integrity, miRNAs are encapsulated in specific vesicles, in order to prevent their degradation by the enzymes present in biological fluids. In this context, the chance of monitoring the expression levels of specific miRNAs represents a very interesting option both for an early diagnosis and for monitoring the clinical response to pharmacological treatment. Currently, there are no non-invasive approaches to monitor the clinical outcome in real time, while the identification of circulating biomarkers would allow prompt intervention, possibly modifying the pharmacological management in case of progression.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Histological diagnosis of epithelial ovarian cancer
  • Patients eligible for surgery
  • Patients followed in the clinical care pathway c / o oncological gynecology (surgery and follow up)
  • informed consent

排除标准

  • Patients with HCV, HBV and HIV
  • Patients with other malignancies diagnosed less than 5 years prior to the diagnosis of ovarian malignancy
  • Ovarian metastases of primary neoplasms of other organs
  • Presence of ascites for non-neoplastic causes

结局指标

主要结局

Longitudinal miRNAs analysis over chemotherapy

时间窗: 2 years

Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up

次要结局

  • Associaition miRNA-clinico-pathological data(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Myriam Perrone

MD

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

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