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miRNAs in High Grade Serous Ovarian Cancer

Analysis of Circulating miRNAs as Potential Biomarkers of Diagnosis and Prognosis in High Grade Serous Ovarian Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05146505
Acronym
MIROC
Enrollment
150
Registered
2021-12-06
Start date
2021-10-01
Completion date
2023-10-01
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Grade Serous Ovarian Cancer

Keywords

miRNAs

Brief summary

High grade serous ovarian cancer represents the gynecological malignancy with the highest incidence of mortality. Decision-making tools are currently limited to the use of standard imaging modalities and analysis of serum biomarkers, such as CA 125, which often have low specificity and sensitivity. Recently, a growing research interest has been aimed at so-called circulating microRNAs (miRNAs). Indeed, it has been observed that miRNAs are abundantly present in all biological fluids and play the key role of messengers in intercellular communication. Cancer cells have a rapid turnover which results in a continuous release of nucleic acids and vesicles derived from the tumor itself, such as the tumor cells themselves that separate from the tumor mass to enter the bloodstream. Given their important role as modulators of gene expression, in order to preserve their integrity, miRNAs are encapsulated in specific vesicles, in order to prevent their degradation by the enzymes present in biological fluids. In this context, the chance of monitoring the expression levels of specific miRNAs represents a very interesting option both for an early diagnosis and for monitoring the clinical response to pharmacological treatment. Currently, there are no non-invasive approaches to monitor the clinical outcome in real time, while the identification of circulating biomarkers would allow prompt intervention, possibly modifying the pharmacological management in case of progression.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* age\>18 * Histological diagnosis of epithelial ovarian cancer * Patients eligible for surgery * Patients followed in the clinical care pathway c / o oncological gynecology (surgery and follow up) * informed consent

Exclusion criteria

* Patients with HCV, HBV and HIV * Patients with other malignancies diagnosed less than 5 years prior to the diagnosis of ovarian malignancy * Ovarian metastases of primary neoplasms of other organs * Presence of ascites for non-neoplastic causes

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal miRNAs analysis over chemotherapy2 yearsEvaluation of miRNA expression in longitudinal blood samples collected during every follow-up

Secondary

MeasureTime frameDescription
Associaition miRNA-clinico-pathological data2 yearsCorrelation between miRNAs deregulation and clinico-pathological and molecular data

Countries

Italy

Contacts

Primary ContactAnna Myriam Perrone, MD
myriam.perrone@aosp.bo.it+39 051 2144392
Backup ContactAnna Myriam Perrone
myriam.perrone@aosp.bo.it+39 051 2144392

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026