Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065908
• Other study ID #: ZCO-2014-BD
• Status: Completed
• Phase: N/A
• First received: February 15, 2014
• Last updated: December 7, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: West Pomeranian Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

Locations

Country	Name	City	State
Poland	Collegium Medicum of Jagiellonian University	Cracow
Poland	Clinical Oncology Department, West Pomeranian Cancer Center	Szczecin	West Pomeranian
Poland	Pomeranian Medical University, Department of Cardiology	Szczecin

Sponsors (2)

Lead Sponsor	Collaborator
West Pomeranian Cancer Center	Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria	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	Yes