Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
NCT ID: NCT02065908
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
128 participants
OBSERVATIONAL
2014-01-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* stage I-III TNM (Tumor Node Metastases)
Exclusion Criteria
* previously treated with chemotherapy
* previously treated with radiotherapy
* acute myocardial infarction
* heart failure
* cardiomyopathy
18 Years
70 Years
FEMALE
No
Sponsors
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Pomeranian Medical University Szczecin
OTHER
West Pomeranian Cancer Center
OTHER
Responsible Party
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Bartosz Dąbek
MD
Principal Investigators
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Bartosz Dąbek, MD
Role: PRINCIPAL_INVESTIGATOR
West Pomeranian Cancer Center
Locations
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Clinical Oncology Department, West Pomeranian Cancer Center
Szczecin, West Pomeranian Voivodeship, Poland
Collegium Medicum of Jagiellonian University
Krakow, , Poland
Pomeranian Medical University, Department of Cardiology
Szczecin, , Poland
Countries
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Other Identifiers
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ZCO-2014-BD
Identifier Type: -
Identifier Source: org_study_id