Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02065908
• Lead Sponsor: West Pomeranian Cancer Center

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-15
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-19
• Primary Completion: 2016-06
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-07
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• age 18-70
• stage I-III TNM (Tumor Node Metastases)

Exclusion Criteria

• second or next cancer (except for basal cell skin cancer and CIN)
• previously treated with chemotherapy
• previously treated with radiotherapy
• acute myocardial infarction
• heart failure
• cardiomyopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria	up to 76 weeks after chemotherapy conclusion	either a cardiomyopathy with decreased left ventricular ejection fraction (LVEF), a reduction of LVEF ≥5% to \<55% with symptoms of heart failure (e.g. orthopnoea and paroxysmal nocturnal dyspnoea, elevated jugular venous pressure, S3 gallop, Hepatojugular reflux, tachycardia), or an asymptomatic reduction of LVEF ≥10% to \<55%

Trial Locations

Locations (3)

Clinical Oncology Department, West Pomeranian Cancer Center; 🇵🇱 Szczecin, West Pomeranian, Poland

Pomeranian Medical University, Department of Cardiology; 🇵🇱 Szczecin, Poland

Collegium Medicum of Jagiellonian University; 🇵🇱 Cracow, Poland