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Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02065908
First Posted: February 19, 2014
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pomeranian Medical University Szczecin
Information provided by (Responsible Party):
Bartosz Dąbek, West Pomeranian Cancer Center
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines

Resource links provided by NLM:


Further study details as provided by Bartosz Dąbek, West Pomeranian Cancer Center:

Primary Outcome Measures:
  • 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%


Biospecimen Retention:   Samples Without DNA
5 ml of blood will be collected, 2ml of serum will be isolated from the blood and stored below -80C till completion of the study.

Enrollment: 128
Study Start Date: January 2014
Study Completion Date: December 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065908


Locations
Poland
Clinical Oncology Department, West Pomeranian Cancer Center
Szczecin, West Pomeranian, Poland, 71-730
Collegium Medicum of Jagiellonian University
Cracow, Poland, 31-513
Pomeranian Medical University, Department of Cardiology
Szczecin, Poland, 70-111
Sponsors and Collaborators
West Pomeranian Cancer Center
Pomeranian Medical University Szczecin
Investigators
Principal Investigator: Bartosz Dąbek, MD West Pomeranian Cancer Center
  More Information

Responsible Party: Bartosz Dąbek, MD, West Pomeranian Cancer Center
ClinicalTrials.gov Identifier: NCT02065908     History of Changes
Other Study ID Numbers: ZCO-2014-BD
First Submitted: February 15, 2014
First Posted: February 19, 2014
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Bartosz Dąbek, West Pomeranian Cancer Center:
breast cancer
anthracyclines
cardiotoxicity
circulating microRNA
biomarker
serum
anthracyclines based chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries