Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

Breast Cancer Clinical Trial

Official title: Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines

Status Completed

Clinical Trial Summary

In the proposed project the investigators will asses whether changes in expression of selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.

Clinical Trial Description

Blood will be taken

1. before anthracycline based chemotherapy administration

2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)

3. after anthracycline chemotherapy cessation

4. 6 months after chemotherapy cessation if an end point occurs

5. 12 months after chemotherapy cessation if an end point occurs

Echocardiography will be performed

1. before anthracycline based chemotherapy administration

2. after anthracycline based chemotherapy cessation

3. 6 months after anthracycline based chemotherapy cessation

4. 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier The investigators will perform high-throughput miRNA(microRNA) expression profiling of serum samples - called training set.

Training set will consist of sera of 30 patients who has reached an end point. Training set will be sequenced using next generation sequencing.

Training set will be used to derive a miRNA signature capable of separating early cardiotoxicity patients from healthy ones. MiRNA signature will be validated using validation set. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

• NCT number: NCT02065908
• Study type: Observational
• Source: West Pomeranian Cancer Center
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: December 2016