SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
SUMMER
1 other identifier
observational
24
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2024
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2023
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
April 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 26, 2024
March 1, 2024
3 years
December 4, 2023
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Difference in microRNA expression (plasma) between benign and malignant masses
Comparison of heatmaps based on mean expression of clusters across samples
24 months
Difference in microRNA expression (serum) between benign and malignant masses
Comparison of heatmaps based on mean expression of clusters across samples
24 months
microRNA expression (plasma)
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
24 months
microRNA expression (serum)
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
24 months
Secondary Outcomes (8)
Quantitative measure of circulating miRNA before treatment
24 months
Quantitative measure of circulating miRNA before treatment
24 months
Quantitative measure of circulating miRNA after treatment
24 months
Quantitative measure of circulating miRNA after treatment
24 months
Performance of segmentation model on ultrasound images
24 months
- +3 more secondary outcomes
Study Arms (5)
Cases- Malignant Ovarian Germ Cell Tumour - Arm 1
Patients with a diagnosis of stage 1a MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively
Cases - Malignant Ovarian Germ Cell Tumour - Arm 2
Patients with a diagnosis of stage 1b/1c MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively OR post-final dose of adjuvant chemotherapy
Cases - Malignant Ovarian Germ Cell Tumour - Arm 3
Patients with a diagnosis of stage 2 or higher MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks post-neoadjuvant chemotherapy, then 4 weeks; 6 months; 12 months; 24 months post-operatively
Controls - Benign Ovarian Germ Cell Tumour
Bloods taken at the time of diagnosis of BOGCT (single blood test)
Controls - No Known Gynaecological Pathology
Single blood test
Interventions
Serum and plasma microRNA quantification
Pathology specimen mirNA expression - ALL MOGCT; OPTIONAL for BOGCT
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Serum and plasma (microRNA expression); tumour specimen (microRNA expression)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srdjan Saso, PhD MRCOG MRCS
Imperial College Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2023
First Posted
March 25, 2024
Study Start
April 14, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share