Breast Cancer FemaleBREMIRNCT06555354
MicroRNAs and Prognosis in Breast Cancer
An observational study of Breast Cancer Female and Metastases Breast, run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.
Trial summary
Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Metastases Breast
- What is being tested?
- miRNA targeted analysis on breast cancer tissues, miRNA targeted analysis on plasma samples and miRNA profiling of breast cancer tissues
- How many people
- 1,432 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2014to 28 Nov 2019
- 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: Retrospective Cohort: 260 patients diagnosed with breast cancer of any histological type that underwent surgery for breast cancer from 2004 to 2014. For all this subjects fresh frozen specimen collected at the time of surgery are available for DNA and/or RNA extraction. Prospective cohort: 1072 individuals were enrolled in this study from December 2014 to December 2019: 972 patients were affected by breast cancer, 100 patients showed benign breast lesions. For all this subjects fresh frozen specimen and/or FFPE sample at diagnosis, together with a plasma sample collected at the time of surgery are available for DNA and/or RNA extraction. For invasive breast cancer at least two plasma samples were colleted at surgery and after surgery. A third plasma sample is being collected at the eventual progression.
Who may be able to join
- Tissue samples from breast cancer cases diagnosed from 2004 to 2014 for which informed consent for tumour banking and complete clinicopathological and follow up data were available.
- Ability to provide written informed consent; Age greater than 18 years; Histological diagnosis of Breast disease; First diagnosis of Breast Cancer; Syncronous distant metastasis absent.
Who cannot join
- Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.
- Other cancers diagnosed in the last five years.
- Prospective Cohort:
- Stage IV breast cancer; Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen; Other cancers diagnosed in the last five years; Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Casa sollievo della Sofferenza IRCCS
San Giovanni Rotondo, FG, 71013
About this study
Official title: MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases
Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients.
Read the detailed description
The potential role of miRNAs will be studied as a predictor of metastases development. miRNAs expression and miRNAs promoter methylation will be evaluated in surgically removed specimens obtained from breast cancer patients at diagnosis. Relevant miRNAs will be first identified by analysing a retrospective breast cancer cohort including at least and subsequently validated on a prospective cohort.
- Conditions
- Breast Cancer Female, Metastases Breast
- Being tested
- miRNA targeted analysis on breast cancer tissues, miRNA targeted analysis on plasma samples, miRNA profiling of breast cancer tissues
- Keywords
- microRNA, prognosis, risk prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA targeted analysis on breast cancer tissuesDiagnostic test
Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve.
miRNA targeted analysis on plasma samplesDiagnostic test
miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .
miRNA profiling of breast cancer tissuesDiagnostic test
Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Identification in a retrospective cohort of a miRNA panel associated with the development of distant metastases.The retrospective cohort consists of tumor and normal tissue obtained from breast cancer patients, stored at -80°C at the Laboratory of Oncology. Of these samples, 360 met the inclusion criteria. Receives: Diagnostic Test: miRNA targeted analysis on breast cancer tissues; Diagnostic Test: miRNA profiling of breast cancer tissues | |
| Prospective | The association between miRNA expression and the clinical course of the disease identified in the retrospective cohort, is being confirmed in an independent prospective cohort. Both normal and tumor tissues of the patients, as well as plasma collected before surgery and at each follow-up time point, is being analyzed. Based on the annual number of surgeries performed at the Breast Surgery Unit, we initially estimated that the prospective cohort would consist of about 500 patients recruited over three years. Since the project was extended for additional two years the actual number of subject recruited was 972. In addition plasma sample for 100 breast benign condition was also collected as controls. Receives: Diagnostic Test: miRNA targeted analysis on breast cancer tissues; Diagnostic Test: miRNA targeted analysis on plasma samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of metastases development
Identification of miRNAs associated with the risk to develop distant metastases.
Measured: evaluation 5 and 10 years after diagnosis
Secondary outcomes (1)
Overall Survival
Identification of miRNAs associated with the risk of cancer specific death
Measured: evaluation 5 and 10 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start28 Oct 2014
- Primary completion28 Oct 2018
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 1,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Parrella, Casa Sollievo della Sofferenza IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555354
- Sponsor's protocol ID
- BREMIR
- Acronym
- BREMIR
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barbano R, Pasculli B, Rendina M, Fontana A, Fusilli C, Copetti M, Castellana S, Valori VM, Morritti M, Graziano P, Luigi C, Coco M, Picardo F, Mazza T, Evron E, Murgo R, Maiello E, Esteller M, Fazio VM, Parrella P. Stepwise analysis of MIR9 loci identifies miR-9-5p to be involved in Oestrogen regulated pathways in breast cancer patients. Sci Rep. 2017 Mar 27;7:45283. doi: 10.1038/srep45283.
PubMed 28345661Pasculli B, Barbano R, Fontana A, Biagini T, Di Viesti MP, Rendina M, Valori VM, Morritti M, Bravaccini S, Ravaioli S, Maiello E, Graziano P, Murgo R, Copetti M, Mazza T, Fazio VM, Esteller M, Parrella P. Hsa-miR-155-5p Up-Regulation in Breast Cancer and Its Relevance for Treatment With Poly[ADP-Ribose] Polymerase 1 (PARP-1) Inhibitors. Front Oncol. 2020 Aug 12;10:1415. doi: 10.3389/fonc.2020.01415. eCollection 2020.
PubMed 32903519Pasculli B, Barbano R, Rendina M, Fontana A, Copetti M, Mazza T, Valori VM, Morritti M, Maiello E, Graziano P, Murgo R, Fazio VM, Esteller M, Parrella P. Hsa-miR-210-3p expression in breast cancer and its putative association with worse outcome in patients treated with Docetaxel. Sci Rep. 2019 Oct 17;9(1):14913. doi: 10.1038/s41598-019-51581-3.
PubMed 31624308Fontana A, Barbano R, Dama E, Pasculli B, Rendina M, Morritti MG, Melocchi V, Castelvetere M, Valori VM, Ravaioli S, Bravaccini S, Ciuffreda L, Graziano P, Maiello E, Copetti M, Fazio VM, Esteller M, Bianchi F, Parrella P. Combined analysis of miR-200 family and its significance for breast cancer. Sci Rep. 2021 Feb 3;11(1):2980. doi: 10.1038/s41598-021-82286-1.
PubMed 33536459Fontana A, Barbano R, Pasculli B, Mazza T, Palumbo O, Binda E, Trivieri N, Mencarelli G, Laurenzana I, Lamorte D, De Luca L, Caivano A, Biagini T, Rendina M, Lo Mele A, Prencipe G, Bravaccini S, Murgo R, Ciuffreda L, Morritti M, Valori VM, Di Lisa FS, Vici P, Castelvetere M, Carella M, Graziano P, Maiello E, Copetti M, Esteller M, Parrella P. Development of a microRNA-based prognostic model for accurate prediction of distant metastasis in breast cancer patients. Breast Cancer Res. 2025 Sep 29;27(1):170. doi: 10.1186/s13058-025-02124-4.
PubMed 41024243
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases
- ClinicalTrials.gov ID
- NCT06555354
- Acronym / sponsor ID
- BREMIR / BREMIR
- Conditions
- Breast Cancer Female, Metastases Breast
- Keywords
- microRNA, prognosis, risk prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,432 participants (actual)
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCSUniversity, hospital or other
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 15 Aug 2024 (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.
Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients.
Detailed description
The potential role of miRNAs will be studied as a predictor of metastases development. miRNAs expression and miRNAs promoter methylation will be evaluated in surgically removed specimens obtained from breast cancer patients at diagnosis. Relevant miRNAs will be first identified by analysing a retrospective breast cancer cohort including at least and subsequently validated on a prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Diagnostic Test: miRNA targeted analysis on breast cancer tissues, Diagnostic Test: miRNA profiling of breast cancer tissuesIdentification in a retrospective cohort of a miRNA panel associated with the development of distant metastases.The retrospective cohort consists of tumor and normal tissue obtained from breast cancer patients, stored at -80°C at the Laboratory of Oncology. Of these samples, 360 met the inclusion criteria. |
| Prospective | – | Diagnostic Test: miRNA targeted analysis on breast cancer tissues, Diagnostic Test: miRNA targeted analysis on plasma samplesThe association between miRNA expression and the clinical course of the disease identified in the retrospective cohort, is being confirmed in an independent prospective cohort. Both normal and tumor tissues of the patients, as well as plasma collected before surgery and at each follow-up time point, is being analyzed. Based on the annual number of surgeries performed at the Breast Surgery Unit, we initially estimated that the prospective cohort would consist of about 500 patients recruited over three years. Since the project was extended for additional two years the actual number of subject recruited was 972. In addition plasma sample for 100 breast benign condition was also collected as controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective Cohort: 260 patients diagnosed with breast cancer of any histological type that underwent surgery for breast cancer from 2004 to 2014. For all this subjects fresh frozen specimen collected at the time of surgery are available for DNA and/or RNA extraction. Prospective cohort: 1072 individuals were enrolled in this study from December 2014 to December 2019: 972 patients were affected by breast cancer, 100 patients showed benign breast lesions. For all this subjects fresh frozen specimen and/or FFPE sample at diagnosis, together with a plasma sample collected at the time of surgery are available for DNA and/or RNA extraction. For invasive breast cancer at least two plasma samples were colleted at surgery and after surgery. A third plasma sample is being collected at the eventual progression.
Key inclusion criteria (2 listed)
- Tissue samples from breast cancer cases diagnosed from 2004 to 2014 for which informed consent for tumour banking and complete clinicopathological and follow up data were available.
- Ability to provide written informed consent; Age greater than 18 years; Histological diagnosis of Breast disease; First diagnosis of Breast Cancer; Syncronous distant metastasis absent.
Key exclusion criteria (4 listed)
- Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.
- Other cancers diagnosed in the last five years.
- Stage IV breast cancer; Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen; Other cancers diagnosed in the last five years; Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRNA targeted analysis on breast cancer tissuesTotal RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve. | Diagnostic test | Prospective, Retrospective |
| miRNA targeted analysis on plasma samplesmiRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR . | Diagnostic test | Prospective |
| miRNA profiling of breast cancer tissuesSelected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array. | Diagnostic test | Retrospective |
Primary outcome
Risk of metastases development
Time frame: evaluation 5 and 10 years after diagnosis
Identification of miRNAs associated with the risk to develop distant metastases.
1 secondary outcome
Overall Survival
Time frame: evaluation 5 and 10 years after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 28345661Barbano R, Pasculli B, Rendina M, Fontana A, Fusilli C, Copetti M, Castellana S, Valori VM, Morritti M, Graziano P, Luigi C, Coco M, Picardo F, Mazza T, Evron E, Murgo R, Maiello E, Esteller M, Fazio VM, Parrella P. Stepwise analysis of MIR9 loci identifies miR-9-5p to be involved in Oestrogen regulated pathways in breast cancer patients. Sci Rep. 2017 Mar 27;7:45283. doi: 10.1038/srep45283.
- Background: PubMed 32903519Pasculli B, Barbano R, Fontana A, Biagini T, Di Viesti MP, Rendina M, Valori VM, Morritti M, Bravaccini S, Ravaioli S, Maiello E, Graziano P, Murgo R, Copetti M, Mazza T, Fazio VM, Esteller M, Parrella P. Hsa-miR-155-5p Up-Regulation in Breast Cancer and Its Relevance for Treatment With Poly[ADP-Ribose] Polymerase 1 (PARP-1) Inhibitors. Front Oncol. 2020 Aug 12;10:1415. doi: 10.3389/fonc.2020.01415. eCollection 2020.
- Background: PubMed 31624308Pasculli B, Barbano R, Rendina M, Fontana A, Copetti M, Mazza T, Valori VM, Morritti M, Maiello E, Graziano P, Murgo R, Fazio VM, Esteller M, Parrella P. Hsa-miR-210-3p expression in breast cancer and its putative association with worse outcome in patients treated with Docetaxel. Sci Rep. 2019 Oct 17;9(1):14913. doi: 10.1038/s41598-019-51581-3.
- Background: PubMed 33536459Fontana A, Barbano R, Dama E, Pasculli B, Rendina M, Morritti MG, Melocchi V, Castelvetere M, Valori VM, Ravaioli S, Bravaccini S, Ciuffreda L, Graziano P, Maiello E, Copetti M, Fazio VM, Esteller M, Bianchi F, Parrella P. Combined analysis of miR-200 family and its significance for breast cancer. Sci Rep. 2021 Feb 3;11(1):2980. doi: 10.1038/s41598-021-82286-1.
- Derived from this study: PubMed 41024243Fontana A, Barbano R, Pasculli B, Mazza T, Palumbo O, Binda E, Trivieri N, Mencarelli G, Laurenzana I, Lamorte D, De Luca L, Caivano A, Biagini T, Rendina M, Lo Mele A, Prencipe G, Bravaccini S, Murgo R, Ciuffreda L, Morritti M, Valori VM, Di Lisa FS, Vici P, Castelvetere M, Carella M, Graziano P, Maiello E, Copetti M, Esteller M, Parrella P. Development of a microRNA-based prognostic model for accurate prediction of distant metastasis in breast cancer patients. Breast Cancer Res. 2025 Sep 29;27(1):170. doi: 10.1186/s13058-025-02124-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer Female and Metastases Breast, run by Casa Sollievo della Sofferenza IRCCS 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 2 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: finished, as of the sponsor's last update on 15 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of metastases development (time frame: evaluation 5 and 10 years after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06555354, which also lists 5 linked publications.
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 15 Aug 2024.