Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinical Oncology Department, West Pomeranian Cancer Center, Szczecin, West Pomeranian Voivodeship, Poland

About this study

Blood will be taken

before anthracycline based chemotherapy administration
at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
after anthracycline chemotherapy cessation
6 months after chemotherapy cessation if an end point occurs
12 months after chemotherapy cessation if an end point occurs

Echocardiography will be performed

before anthracycline based chemotherapy administration
after anthracycline based chemotherapy cessation
6 months after anthracycline based chemotherapy cessation
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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria

Time frame: 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%

Sponsors and collaborators

Lead sponsor

West Pomeranian Cancer Center

Other

Collaborators

Pomeranian Medical University Szczecin

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Feb 19, 2014
Registry last updated: Dec 8, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed