SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Difference in microRNA expression (plasma) between benign and malignant masses
研究概览
简要总结
The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.
The main question[s] it aims to answer are:
- To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)
- To understand the imaging profile of MOGCTs compared to that of BOGCTs
- To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
- To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
- To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aims
Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.
Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass.
详细描述
Case population (MOGCTs):
- Serum aFP (alpha fetoprotein), hCG (human chorionic gonadotrophin), LDH (lactate dehydrogenase) and Ca125 (cancer antigen 125) tumour markers measured at time of diagnosis
- Additional serum and plasma sample to be obtained at the same time as initial bloods
- Subsequent serum and plasma samples to be obtained as per study arms 1-3 based on cancer staging
- Tissue samples will be obtained at the time of surgery
Control population:
Participants acting as controls will be identified from those attending for TV-USS where either a benign teratoma or no pathology is identified (e.g. from a gynaecology clinic). A total of 26ml of blood will be taken. Serum aFP, hCG, LDH and Ca125 will be measured as per routine clinical practice in patients with a benign OGCT.
Patients in the control population (benign germ cell tumours or patients with no known gynaecological pathology) will have a single blood test for miRNA analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients with a new diagnosis of a malignant ovarian germ cell tumour.
- •The control population will include all patients with a new diagnosis of a benign ovarian germ cell tumour or no known gynaecological pathology.
排除标准
- •Previous or ongoing chemotherapy for MOGCT
- •Previous surgery for MOGCT
- •Pregnancy - this will be verbally communicated for those not having surgery or chemotherapy, for those having surgery or chemotherapy a urine pregnancy test should be negative and documented in the clinical notes.
- •Fetal circulating DNA is known to be present in maternal blood and therefore pregnant women should not be included in this study
- •Denial of informed consent
- •Age <16 years
- •History of any other cancer
结局指标
主要结局
Difference in microRNA expression (plasma) between benign and malignant masses
时间窗: 24 months
Comparison of heatmaps based on mean expression of clusters across samples
microRNA expression (plasma)
时间窗: 24 months
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
microRNA expression (serum)
时间窗: 24 months
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
Difference in microRNA expression (serum) between benign and malignant masses
时间窗: 24 months
Comparison of heatmaps based on mean expression of clusters across samples
次要结局
- Performance of segmentation model on MRI images(24 months)
- Performance of classification model on ultrasound images(24 months)
- Quantitative measure of circulating miRNA before treatment(24 months)
- Performance of classification model on MRI images(24 months)
- Quantitative measure of circulating miRNA after treatment(24 months)
- Performance of segmentation model on ultrasound images(24 months)