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Completed

NCT Number: NCT06555354

MicroRNAs and Prognosis in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Female Metastases Breast

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Casa sollievo della Sofferenza IRCCS

San Giovanni Rotondo, FG, 71013, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

miRNA targeted analysis on breast cancer tissues

Diagnostic 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 samples

Diagnostic Test

miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .

miRNA profiling of breast cancer tissues

Diagnostic Test

Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.

Primary outcomes

  1. Risk of metastases development

    Time frame: evaluation 5 and 10 years after diagnosis

    Identification of miRNAs associated with the risk to develop distant metastases.

Secondary outcomes

  1. Overall Survival

    Time frame: evaluation 5 and 10 years after diagnosis

    Identification of miRNAs associated with the risk of cancer specific death

Sponsors and collaborators

Lead sponsor

Casa Sollievo della Sofferenza IRCCS

Other

Registry information

Official study title

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

Acronym: BREMIR

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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