miRNAs in High Grade Serous Ovarian Cancer

NCT05146505 | Unknown

• 1 other identifier: 788/2021/Sper/AOUBo
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Serous Ovarian Cancer

Keywords

miRNAs

Outcome Measures

Primary Outcomes (1)

• Longitudinal miRNAs analysis over chemotherapy

  Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up

  2 years

Secondary Outcomes (1)

• Associaition miRNA-clinico-pathological data

  2 years

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with high grade serous ovarian cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bo, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA

Study Officials

• Anna Myriam Perrone

  IRCCS Azienda Ospedaliera-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Myriam Perrone, MD

CONTACT

+39 051 2144392; myriam.perrone@aosp.bo.it

Anna Myriam Perrone

CONTACT

+39 051 2144392; myriam.perrone@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 6, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)