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:
1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs) 2. To understand the imaging profile of MOGCTs compared to that of BOGCTs 3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease 4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI 5. 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.
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.
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
Women aged over 16 with a diagnosis of a malignant ovarian germ cell tumour, benign ovarian germ cell tumour or no known gynaecological pathology may take part in this study.
Case-control
Prospective
Blood test
Diagnostic testSerum and plasma microRNA quantification
Pathology specimen miRNA expression
Diagnostic testPathology specimen mirNA expression - ALL MOGCT; OPTIONAL for BOGCT
Difference in microRNA expression (plasma) between benign and malignant masses
Comparison of heatmaps based on mean expression of clusters across samples
Difference in microRNA expression (serum) between benign and malignant masses
Comparison of heatmaps based on mean expression of clusters across samples
microRNA expression (plasma)
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
microRNA expression (serum)
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
Quantitative measure of circulating miRNA before treatment
miRNA expression in plasma samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Quantitative measure of circulating miRNA before treatment
miRNA expression in serum samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Quantitative measure of circulating miRNA after treatment
miRNA expression in plasma samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Quantitative measure of circulating miRNA after treatment
miRNA expression in serum samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
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