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BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study (BACCARAT)

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ClinicalTrials.gov Identifier: NCT02605512
Recruitment Status : Unknown
Verified June 2018 by Sophie JACOB, Institut de Radioprotection et de Surete Nucleaire.
Recruitment status was:  Recruiting
First Posted : November 16, 2015
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Institut de Radioprotection et de Surete Nucleaire
Clinique Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Sophie JACOB, Institut de Radioprotection et de Surete Nucleaire

Tracking Information
First Submitted Date  ICMJE November 6, 2015
First Posted Date  ICMJE November 16, 2015
Last Update Posted Date June 19, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2015)
  • Number of patients with decreased myocardial function assessed by echocardiography [ Time Frame: 2 years after 3DCRT (baseline measures performed before radiotherapy) ]
    Number of patients with a decrease in the mean strain or strain rate measured from the echocardiography of the order of 5% between the measurement before RT and 24 months after RT
  • Number of patients with increased coronary plaques assessed by CT coronary angiography [ Time Frame: 2 years after 3DCRT (baseline measures performed before radiotherapy) ]
    Number of patients with an increase of the average index of coronary plaques measured from the CT coronary angiography in the order of 15% between the measurements before RT and 24 months after RT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2015)
  • Decrease in the strain or strain rate [ Time Frame: 6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy) ]
  • Modification in series of circulating biomarkers of cardiac lesions [ Time Frame: 5 weeks after initiation of 3DCRT (corresponding to the end of 3DCRT sessions), 6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy) ]
    Classical biomarkers of cardiac injury: C-reactive protein, Troponin I, B-type natriuretic peptide (NT-Pro BNP), beta2-Microglobulin, Galectin 3 / Inflammatory cytokines: Interleukin 6, Interleukin 8, Interleukin 18, TNF-α / Endothelial activation and dysfunction: sVCAM,-1 , s-ICAM-1, E-selectin, P-selectin , vWF, PAI-1, Fibrinogen , Thrombomodulin, TGF-β1 / Microparticles: CD14, CD31, CD41, CD3, CD235a / microRNAs : miR-1, miR-133, miR-208, miR-499, miR-126, miR-130, miR-145, miR-181, miR-150, miR-155, miR-223, miR-17, miR-18, miR-22, miR-34, miR-92, miR-140, miR-182, miR-199, miR-423, miR-590
  • Correlation between the absorbed radiation dose by the whole heart and different structures of the heart and measurements of strain and strain rate and indices of coronary plaques [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study
Official Title  ICMJE Early Detection and Prediction of Cardiotoxicity in Radiotherapy-treated Breast Cancer Patients
Brief Summary Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality due to long term cardiac complications. Since the 2000s, improvements have appeared in dose distributions to organ at risks such as heart, but now, little is known on the risk of potential cardiac impairment in this population, in particular for chemotherapy naive patients. Based on the state that clinically detectable cardiotoxicity is generally preceded by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces cardiac toxicity that could be detected in the first two years after treatment based on a global approach with repeated analysis of subclinical functional and anatomical cardiac lesions in myocardial and coronary levels and circulating biomarkers.
Detailed Description

BACCARAT study consists in a monocentric prospective cohort study that will finally include 120 women treated with adjuvant RT for breast cancer in the Clinique Pasteur in Toulouse, and followed for 2 years after RT.

Women aged 50 to 70 years, treated for breast cancer and for whom adjuvant 3DCRT is indicated, without chemotherapy are eligible for the study.

Baseline and follow-up include measures of functional myocardial dysfunction based on 2D-speckle tracking echocardiography, anatomical coronary lesions based on Coronary computed tomography angiography, and a wide panel of circulating biomarkers. Absorbed doses is evaluated for whole heart and for each different parts of heart, in particular coronary arteries.

Analysis on occurrence and evolutions of subclinical cardiac lesions and biomarkers will be performed and completed with dose-response relations with absorbed doses of different heart segments.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Breast Cancer
  • Cardiac Toxicity
Intervention  ICMJE Other: Subclinical cardiac lesions and biomarkers
Functional myocardial dysfunction based on 2D-speckle tracking echocardiography, Anatomical coronary lesions based on Coronary computed tomography angiography, a panel of circulating biomarkers based on blood samples and plasma
Study Arms  ICMJE Breast cancer patients with 3DCRT
Measures of subclinical functional and anatomical cardiac lesions and circulating biomarkers 'Subclinical cardiac lesions and biomarkers'
Intervention: Other: Subclinical cardiac lesions and biomarkers
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 11, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 50 and 70 years
  • Women surgically treated for left or right breast cancer and for whom adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly ganglion chains,
  • Adjuvant radiotherapy with 3DCRT performed in Clinique Pasteur Toulouse
  • WHO performance status ECOG - Eastern Cooperative Oncology Group (index normally used to describe the patient's condition) = 0 or 1
  • Being volunteer to participate in the study and have signed the consent form

Exclusion Criteria:

  • Indication of adjuvant chemotherapy
  • Clinically or radiologically detectable metastasis
  • Personal history of coronary artery disease or myocardial disease
  • Personal history of breast cancer or other cancer requiring radiotherapy to the thorax
  • Patient with controlled infection or severe disease and / or non-hazardous to their participation in the study
  • Contraindications to injection of iodinated contrast (for CCTA): pregnancy, renal failure, allergy.
  • Pregnancy, lactation
  • Abnormal echocardiography before radiotherapy:
  • LVEF <50%
  • Longitudinal strain> - 16%
  • Longitudinal strain rate <1% / s
  • Abnormal wall motion
  • CCTA before radiotherapy showing that therapeutic management is required (coronary-artery calcium (CAC) score>600)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02605512
Other Study ID Numbers  ICMJE IRSN_2015-A00990-49
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sophie JACOB, Institut de Radioprotection et de Surete Nucleaire
Study Sponsor  ICMJE Sophie JACOB
Collaborators  ICMJE
  • Institut de Radioprotection et de Surete Nucleaire
  • Clinique Pasteur
  • Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Atul Pathak, MD PhD Clinique Pasteur Toulouse
PRS Account Institut de Radioprotection et de Surete Nucleaire
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP