Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

NCT02065908 | Completed

• 1 other identifier: ZCO-2014-BD
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

breast cancer; anthracyclines; cardiotoxicity; circulating microRNA; biomarker; serum; anthracyclines based chemotherapy

Outcome Measures

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%

  up to 76 weeks after chemotherapy conclusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Pomeranian Cancer Center: lead
• Pomeranian Medical University Szczecin: collaborator

Study Sites (3)

Clinical Oncology Department, West Pomeranian Cancer Center

Szczecin, West Pomeranian Voivodeship, 71-730, Poland

Location

Collegium Medicum of Jagiellonian University

Krakow, 31-513, Poland

Location

Pomeranian Medical University, Department of Cardiology

Szczecin, 70-111, Poland

Location

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.

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Bartosz Dąbek, MD

  West Pomeranian Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 19, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

PL (3)