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Spots Global Cancer Trial Database for Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

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Trial Identification

Brief Title: Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

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

Study ID: NCT02065908

Conditions

Breast Cancer

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Collegium Medicum of Jagiellonian University, Cracow, , Poland

Pomeranian Medical University, Department of Cardiology, Szczecin, , Poland

Contact Details

Name: Bartosz Dąbek, MD

Affiliation: West Pomeranian Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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