Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02065908

Enrollment

128

Registered

2014-02-19

Start date

2014-01-31

Completion date

2016-12-31

Last updated

2016-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, anthracyclines, cardiotoxicity, circulating microRNA, biomarker, serum, anthracyclines based chemotherapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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%

Countries

Poland

Outcome results