SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours

NCT06329323NOT_YET_RECRUITINGOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Imperial College London

Enrollment

24

Start Date

2024-04-14

Completion Date

2027-04-01

Study Type

OBSERVATIONAL

Official Title

SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours

Interventions

Blood testPathology specimen miRNA expression

Conditions

Germ Cell Ovarian CancerGerm Cell TumorGerm Cell CancerGerm Cell NeoplasiaOvary CancerOvary NeoplasmOvarian CancerOvarian Neoplasms

Eligibility

Age Range

16 Years+

Sex

FEMALE

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Outcome Measures

Primary Outcomes

Difference in microRNA expression (plasma) between benign and malignant masses

Comparison of heatmaps based on mean expression of clusters across samples

Time frame: 24 months

Difference in microRNA expression (serum) between benign and malignant masses

Comparison of heatmaps based on mean expression of clusters across samples

Time frame: 24 months

microRNA expression (plasma)

Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)

Time frame: 24 months

microRNA expression (serum)

Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)

Time frame: 24 months

Secondary Outcomes

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

Time frame: 24 months

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

Time frame: 24 months

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

Time frame: 24 months

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

Time frame: 24 months

Performance of segmentation model on ultrasound images

Correlation between identification of region of interest (ROI) to examiner segmentation. Dice surface coefficient (DICE).

Time frame: 24 months

Performance of segmentation model on MRI images

Correlation between identification of region of interest (ROI) to examiner segmentation. Dice surface coefficient (DICE)

Time frame: 24 months

Performance of classification model on ultrasound images

Correlation between benign or malignant diagnosis by model vs ultrasound subjective assessment or histopathological diagnosis (area under the ROC curve (AUC), F1-score)

Time frame: 24 months

Performance of classification model on MRI images

Correlation between benign or malignant diagnosis by model vs ultrasound subjective assessment or histopathological diagnosis (area under the ROC curve (AUC), F1-score)

Time frame: 24 months

SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours