High Grade Serous Ovarian CancerMIROCNCT05146505
miRNAs in High Grade Serous Ovarian Cancer
An observational study of High Grade Serous Ovarian Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- High Grade Serous Ovarian Cancer
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with high grade serous ovarian cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS- Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bo, 40138
Anna Myriam Perrone, MD
Anna Myriam Perrone
About this study
Official title: 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.
- Conditions
- High Grade Serous Ovarian Cancer
- Keywords
- miRNAs
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal miRNAs analysis over chemotherapy
Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up
Measured: 2 years
Secondary outcomes (1)
Associaition miRNA-clinico-pathological data
Correlation between miRNAs deregulation and clinico-pathological and molecular data
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Serous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Myriam Perrone, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Anna Myriam Perrone, Principal investigator, IRCCS Azienda Ospedaliera-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146505
- Sponsor's protocol ID
- 788/2021/Sper/AOUBo
- Acronym
- MIROC
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating miRNAs as Potential Biomarkers of Diagnosis and Prognosis in High Grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05146505
- Acronym / sponsor ID
- MIROC / 788/2021/Sper/AOUBo
- Conditions
- High Grade Serous Ovarian Cancer
- Keywords
- miRNAs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with high grade serous ovarian cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal miRNAs analysis over chemotherapy
Time frame: 2 years
Evaluation of miRNA expression in longitudinal blood samples collected during every follow-up
1 secondary outcome
Associaition miRNA-clinico-pathological data
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Myriam Perrone principal investigator
IRCCS Azienda Ospedaliera-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Serous Ovarian Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Myriam Perrone, MD (+39 051 2144392, myriam.perrone@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal miRNAs analysis over chemotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.