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SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours

NCT06329323 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2024-03-26

No results posted yet for this 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.

Conditions

  • Germ Cell Ovarian Cancer
  • Germ Cell Tumor
  • Germ Cell Cancer
  • Germ Cell Neoplasia
  • Ovary Cancer
  • Ovary Neoplasm
  • Ovarian Cancer
  • Ovarian Neoplasms

Interventions

DIAGNOSTIC_TEST

Blood test

Serum and plasma microRNA quantification

DIAGNOSTIC_TEST

Pathology specimen miRNA expression

Pathology specimen mirNA expression - ALL MOGCT; OPTIONAL for BOGCT

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Srdjan Saso, PhD MRCOG MRCS · Imperial College Healthcare NHS Trust

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-14
Primary Completion
2027-04-30
Completion
2028-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06329323 on ClinicalTrials.gov