Clinical trial NCT02065908: Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
Official title: Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
anthracyclines
cardiotoxicity
circulating microRNA
biomarker
serum
anthracyclines based chemotherapy
Lead sponsor: West Pomeranian Cancer Center
Sponsor class: OTHER
Collaborators: name: Pomeranian Medical University Szczecin
First posted: 2014-02-19
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.

Brief 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.

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 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

Primary outcomes:
measure: Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria
timeFrame: up to 76 weeks after chemotherapy conclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Clinical Oncology Department, West Pomeranian Cancer Center
state: West Pomeranian
city: Cracow
country: Poland
facility: Collegium Medicum of Jagiellonian University
city: Szczecin
country: Poland
facility: Pomeranian Medical University, Department of Cardiology
Study officials:
affiliation: West Pomeranian Cancer Center
name: Bartosz Dąbek, MD
role: PRINCIPAL_INVESTIGATOR
References: