NCT06555354

MicroRNAs and Prognosis in Breast Cancer

MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,432 (actual)
• Sponsor: Casa Sollievo della Sofferenza IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	miRNA targeted analysis on breast cancer tissues	Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve.
DIAGNOSTIC_TEST	miRNA targeted analysis on plasma samples	miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .
DIAGNOSTIC_TEST	miRNA profiling of breast cancer tissues	Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.

Timeline

• Start date: 2014-10-28
• Primary completion: 2018-10-28
• Completion: 2019-11-28
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: Italy