miRNAs in High Grade Serous Ovarian Cancer

High Grade Serous Ovarian Cancer Clinical Trial

— MIROC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146505
• Other study ID #: 788/2021/Sper/AOUBo
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Anna Myriam Perrone, MD
• Phone: +39 051 2144392
• Email: myriam.perrone[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• High Grade Serous Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Italy	IRCCS- Azienda Ospedaliera-Universitaria di Bologna	Bologna	Bo

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal miRNAs analysis over chemotherapy	Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up	2 years
Secondary	Associaition miRNA-clinico-pathological data	Correlation between miRNAs deregulation and clinico-pathological and molecular data	2 years