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SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours

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clinicaltrials.gov/study/NCT06329323
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT063293230
Health Conditions in Trial
Ovarian cancer
Ovarian cancer
0
Germ cell tumor
Germ cell tumor
0
Trial Recruitment Size
240
Trial Sponsor
Imperial College London
Imperial College London
0
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Imperial College London
0
Clinical Trial Start Date
April 14, 2024
0
Primary Completion Date
2027
0
Study Completion Date
2028
0
Clinical Trial Study Type
Observational0
Intervention Type
Diagnostic Test0
Observational Clinical Trial Type
Case-Control0
Observational Study Perspective
Prospective0
Official Name
SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours0
Last Updated
March 25, 2024
0

Other attributes

Intervention Treatment
Blood test0
Pathology specimen miRNA expression0
Study summary

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.

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