- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065908
Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
December 7, 2016 updated by: Bartosz Dąbek, West Pomeranian Cancer Center
Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
128
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cracow, Poland, 31-513
- Collegium Medicum of Jagiellonian University
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Szczecin, Poland, 70-111
- Pomeranian Medical University, Department of Cardiology
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West Pomeranian
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Szczecin, West Pomeranian, Poland, 71-730
- Clinical Oncology Department, West Pomeranian Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%
|
up to 76 weeks after chemotherapy conclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bartosz Dąbek, MD, West Pomeranian Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
February 15, 2014
First Submitted That Met QC Criteria
February 18, 2014
First Posted (Estimate)
February 19, 2014
Study Record Updates
Last Update Posted (Estimate)
December 8, 2016
Last Update Submitted That Met QC Criteria
December 7, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZCO-2014-BD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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