An observational study in Breast Cancer Female and Metastases Breast, sponsored by Casa Sollievo della Sofferenza IRCCS. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Casa Sollievo della Sofferenza IRCCS · Observational
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.
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.
Casa Sollievo della Sofferenza IRCCS is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Retrospective Cohort
Inclusion Criteria:
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.
Exclusion Criteria:
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:
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Diagnostic Test: miRNA targeted analysis on breast cancer tissues · Diagnostic Test: miRNA profiling of breast cancer tissues
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.
Diagnostic Test: miRNA targeted analysis on breast cancer tissues · Diagnostic Test: miRNA targeted analysis on plasma samples
Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve.
miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .
Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.
Risk of metastases development
Identification of miRNAs associated with the risk to develop distant metastases.
Time frame: evaluation 5 and 10 years after diagnosis
Overall Survival
Identification of miRNAs associated with the risk of cancer specific death
Time frame: evaluation 5 and 10 years after diagnosis
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Casa Sollievo della Sofferenza IRCCS