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miRNAs in High Grade Serous Ovarian Cancer

NCT ID: NCT05146505

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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High Grade Serous Ovarian Cancer

Keywords

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miRNAs

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Anna Myriam Perrone

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Myriam Perrone

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Locations

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IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bo, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Myriam Perrone, MD

Role: CONTACT

Phone: +39 051 2144392

Email: [email protected]

Anna Myriam Perrone

Role: CONTACT

Phone: +39 051 2144392

Email: [email protected]

Facility Contacts

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Anna Myriam Perrone, MD

Role: primary

Other Identifiers

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788/2021/Sper/AOUBo

Identifier Type: -

Identifier Source: org_study_id