Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
This trial has been completed.
|Sponsor||West Pomeranian Cancer Center|
|Collaborator||Pomeranian Medical University Szczecin|
|Start date||January 2014|
|End date||June 2016|
|Trial size||128 participants|
|Trial identifier||NCT02065908, ZCO-2014-BD|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Szczecin, Poland||Clinical Oncology Department, West Pomeranian Cancer Center||completed|
|Cracow, Poland||Collegium Medicum of Jagiellonian University||completed|
|Szczecin, Poland||Pomeranian Medical University, Department of Cardiology||completed|
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria
time frame: up to 76 weeks after chemotherapy conclusion
Female participants from 18 years up to 70 years old.
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
|Official title||Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines|
|Principal investigator||Bartosz Dąbek, MD|
|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.|
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