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

  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.

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

      • Cracow, Poland, 31-513
        • Collegium Medicum of Jagiellonian University
      • Szczecin, Poland, 70-111
        • Pomeranian Medical University, Department of Cardiology
    • West Pomeranian
      • Szczecin, West Pomeranian, Poland, 71-730
        • Clinical Oncology Department, West Pomeranian Cancer Center

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.

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

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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