Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by West Pomeranian Cancer Center
Sponsor:
Collaborator:
Pomeranian Medical University Szczecin
Information provided by (Responsible Party):
Bartosz Dąbek, West Pomeranian Cancer Center
ClinicalTrials.gov Identifier:
NCT02065908
First received: February 15, 2014
Last updated: March 22, 2014
Last verified: March 2014

February 15, 2014
March 22, 2014
January 2014
June 2016   (final data collection date for primary outcome measure)
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria [ Time Frame: up to 76 weeks after chemotherapy conclusion ] [ Designated as safety issue: Yes ]
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%
Same as current
Complete list of historical versions of study NCT02065908 on ClinicalTrials.gov Archive Site
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Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.

Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2016
June 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Bartosz Dąbek, MD bdabek@onkologia.szczecin.pl
Contact: Paweł Stachowiak, MD stachowiak22@gmail.com
Poland
 
NCT02065908
ZCO-2014-BD
No
Bartosz Dąbek, West Pomeranian Cancer Center
West Pomeranian Cancer Center
Pomeranian Medical University Szczecin
Principal Investigator: Bartosz Dąbek, MD West Pomeranian Cancer Center
West Pomeranian Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP