miRNAs in High Grade Serous Ovarian Cancer (MIROC)

December 3, 2021 updated by: Anna Myriam Perrone, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

High Grade Serous Ovarian Cancer

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Anna Myriam Perrone, MD
Phone Number: +39 051 2144392
Email: myriam.perrone@aosp.bo.it

Study Contact Backup

Name: Anna Myriam Perrone
Phone Number: +39 051 2144392
Email: myriam.perrone@aosp.bo.it

Study Locations

Italy
- Bo
  - Bologna, Bo, Italy, 40138
    - Recruiting
    - IRCCS- Azienda Ospedaliera-Universitaria di Bologna
    - Contact:
      
      Anna Myriam Perrone, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with high grade serous ovarian cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal miRNAs analysis over chemotherapy Time Frame: 2 years	Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associaition miRNA-clinico-pathological data Time Frame: 2 years	Correlation between miRNAs deregulation and clinico-pathological and molecular data	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Anna Myriam Perrone, IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 20, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)