跳至主要内容
临床试验/NCT05953883
NCT05953883进行中(未招募)不适用

Proteogenomic Signatures Analysis In Ovarian Cancer, Longitudinal Modification On Tumor Tissue Before And After Platinum-Based Neoadjuvant Chemotherapy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 24 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
进行中(未招募)
入组人数
24
试验地点
1
主要终点
DATA CORRELATION

研究概览

简要总结

Proteogenomic analysis to detect individual platinum-induced modifications on tumor tissue of HGSC according to chemotherapy response score (CRS), using a combined approach of High resolution liquid chromatography mass Spectrometry based platform (HR-LC-MS/MS and advanced immunometric methods on illumine platform); multiple supervised machine learning algorithms will be used to discover proteogenomic signatures and biological processes associated with platinum modification during the neoadjuvant chemotherapy treatment. These results contribute to precision medicine by building an accurate proteogenomic profile of ovarian cancer, in order to better understand the underlying mechanisms of different chemotherapy response among affected patients.

研究设计

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

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

  • Newly diagnosed advanced International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater epithelial ovarian cancer addressed to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS);
  • Availability of freshly frozen tissue and FFPE tissue from both exploratory laparoscopy (baseline) and IDS;
  • Age between 18 and 80 years;
  • Estimated life expectancy of at least 4 weeks;
  • Signed informed consent

排除标准

  • Non-serous histology at frozen section;
  • Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment;
  • Previous diagnosis of cancer within 5 years.

结局指标

主要结局

DATA CORRELATION

时间窗: 12 months

To correlate longitudinal protegenomic data to chemotherapy response score (CRS)

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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