Breast CancerNCT02065908
Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer
An observational study of Breast Cancer, run by West Pomeranian Cancer Center at 3 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 128 participants
- Where
- 3 sitesPoland
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.
Who may be able to join
- age 18-70
- stage I-III TNM (Tumor Node Metastases)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Collegium Medicum of Jagiellonian University
Cracow, 31-513
Clinical Oncology Department, West Pomeranian Cancer Center
Szczecin, West Pomeranian Voivodeship, 71-730
Pomeranian Medical University, Department of Cardiology
Szczecin, 70-111
About this study
Official title: 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.
Read the detailed description
Blood will be taken
- before anthracycline based chemotherapy administration
- at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
- after anthracycline chemotherapy cessation
- 6 months after chemotherapy cessation if an end point occurs
- 12 months after chemotherapy cessation if an end point occurs
Echocardiography will be performed
- before anthracycline based chemotherapy administration
- after anthracycline based chemotherapy cessation
- 6 months after anthracycline based chemotherapy cessation
- 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.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, anthracyclines, cardiotoxicity, circulating microRNA, biomarker, serum, anthracyclines based chemotherapy
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: up to 76 weeks after chemotherapy conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Pomeranian Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pomeranian Medical University Szczecin
- Responsible party
- Principal investigator, Bartosz Dąbek, West Pomeranian Cancer Center
- Investigators
- Bartosz Dąbek, MD, Principal investigator, West Pomeranian Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065908
- Sponsor's protocol ID
- ZCO-2014-BD
- Status last verified
- Dec 2016
- First submitted
- 15 Feb 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines
- ClinicalTrials.gov ID
- NCT02065908
- Acronym / sponsor ID
- ZCO-2014-BD
- Conditions
- Breast Cancer
- Keywords
- breast cancer, anthracyclines, cardiotoxicity, circulating microRNA, biomarker, serum, anthracyclines based chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- West Pomeranian Cancer CenterUniversity, hospital or other
- Collaborators
- Pomeranian Medical University Szczecin
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- before anthracycline based chemotherapy administration
- at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
- after anthracycline chemotherapy cessation
- 6 months after chemotherapy cessation if an end point occurs
- 12 months after chemotherapy cessation if an end point occurs
Echocardiography will be performed
- before anthracycline based chemotherapy administration
- after anthracycline based chemotherapy cessation
- 6 months after anthracycline based chemotherapy cessation
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with newly diagnosed breast cancer that will be treated with anthracyclines will be recruited.
Key inclusion criteria (2 listed)
- age 18-70
- stage I-III TNM (Tumor Node Metastases)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria
Time frame: up to 76 weeks after chemotherapy conclusion
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartosz Dąbek, MD principal investigator
West Pomeranian Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by West Pomeranian Cancer Center at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotoxicity events according to CREC (Cardiac Review and evaluation Committee) criteria (time frame: up to 76 weeks after chemotherapy conclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.