Endometrial CancerMIRCENCT04845425
Analysis of miRNA Expression in Endometrial Cancer
An observational study of Endometrial Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to Dec 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with endometrial cancer
Who may be able to join
- age>18yo
- histological diagnosis of endometrial cancer
- tumor resection
- patient's informed consent
Who cannot join
- patients with other neoplasia within the last 5 years
Trial locations and contacts
1 site in 1 country.
Anna Myriam Perrone contact
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: Identification of miRNAs in Endometrial Cancer as Novel Diagnostic and Prognostic Biomarkers
The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, miRNA, microRNA, TGCA
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of miRNA expression based on the 4 molecular groups
Evaluate miRNA expression based on the 4 molecular groups recently identified
Measured: 1 year
Secondary outcomes (1)
Integration of molecular results with clinico-pathological data
Integration of molecular results with clinico-pathological data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Apr 2021
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Cohort
- Time perspective
- Retrospective
- 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
- NCT04845425
- Sponsor's protocol ID
- 189/2021/Oss/AOUBo
- Acronym
- MIRCE
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2021
- Last updated
- 21 Jul 2022
- 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 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of miRNAs in Endometrial Cancer as Novel Diagnostic and Prognostic Biomarkers
- ClinicalTrials.gov ID
- NCT04845425
- Acronym / sponsor ID
- MIRCE / 189/2021/Oss/AOUBo
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, miRNA, microRNA, TGCA
- 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 Apr 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Apr 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.
The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with endometrial cancer
Key inclusion criteria (4 listed)
- age>18yo
- histological diagnosis of endometrial cancer
- tumor resection
- patient's informed consent
Key exclusion criteria (1 listed)
- patients with other neoplasia within the last 5 years
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
Evaluation of miRNA expression based on the 4 molecular groups
Time frame: 1 year
Evaluate miRNA expression based on the 4 molecular groups recently identified
1 secondary outcome
Integration of molecular results with clinico-pathological data
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
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Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
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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 contact
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 Endometrial 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 4 inclusion and 1 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 21 Jul 2022. 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 (+39-3498359048, 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?
Evaluation of miRNA expression based on the 4 molecular groups (time frame: 1 year). 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 21 Jul 2022.