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CompletedNCT02065908Updated Dec 8, 2016

Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

An observational study in Breast Cancer, sponsored by West Pomeranian Cancer Center. Completed at 3 sites in Poland. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by West Pomeranian Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
128
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • breast cancer
  • anthracyclines
  • cardiotoxicity
  • circulating microRNA
  • biomarker
  • serum
  • anthracyclines based chemotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 128 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with West Pomeranian Cancer Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

Inclusion criteria

  • age 18-70
  • stage I-III TNM (Tumor Node Metastases)

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
128 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: up to 76 weeks after chemotherapy conclusion

07

Study locations

3 sites
  • Clinical Oncology Department, West Pomeranian Cancer Center
    Szczecin, West Pomeranian 71-730, Poland
  • Collegium Medicum of Jagiellonian University
    Cracow, 31-513, Poland
  • Pomeranian Medical University, Department of Cardiology
    Szczecin, 70-111, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02065908
Lead sponsor
West Pomeranian Cancer Center
Collaborators
Pomeranian Medical University Szczecin
Responsible party
Bartosz Dąbek (MD, West Pomeranian Cancer Center) — Principal investigator
First posted
Feb 19, 2014
Start date
Jan 2014
Primary completion
Jun 2016
Completion
Dec 2016
Last update
Dec 8, 2016

Study contacts

Bartosz Dąbek, MD
principal investigator · West Pomeranian Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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