Clinical trial · Observational
SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Cancer | Malignant Germ Cell Tumor | ALIAS | 0.90 |
| Germ Cell Neoplasia | — | UNRESOLVED | — |
| Germ Cell Ovarian Cancer | — | UNRESOLVED | — |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovary Cancer | — | UNRESOLVED | — |
| Ovary Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood test | Diagnostic Test | — | UNRESOLVED |
| Pathology specimen miRNA expression | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Cases- Malignant Ovarian Germ Cell Tumour - Arm 1
- description
- 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
- interventionNames
- Diagnostic Test: Blood test
- Diagnostic Test: Pathology specimen miRNA expression
- label
- Cases - Malignant Ovarian Germ Cell Tumour - Arm 2
- description
- 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
- interventionNames
- Diagnostic Test: Blood test
- Diagnostic Test: Pathology specimen miRNA expression
- label
- Cases - Malignant Ovarian Germ Cell Tumour - Arm 3
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available