Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor West Pomeranian Cancer Center
Collaborator Pomeranian Medical University Szczecin
Start date January 2014
End date June 2016
Trial size 150 participants
Trial identifier NCT02065908, ZCO-2014-BD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria
time frame: up to 76 weeks after chemotherapy conclusion

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by West Pomeranian Cancer Center.