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Genetics and Heart Health After Cancer Therapy (Gene-HEART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03510689
Recruitment Status : Active, not recruiting
First Posted : April 27, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date April 18, 2018
First Posted Date April 27, 2018
Last Update Posted Date October 14, 2020
Actual Study Start Date December 5, 2017
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2018)
Left Ventricular Ejection Fraction [ Time Frame: 6 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetics and Heart Health After Cancer Therapy
Official Title Genetics and Heart Health After Cancer Therapy
Brief Summary The overall objective of this study is to use patient-centered in vitro and in vivo models to answer the fundamental question of whether or not pathogenic mutations in BRCA1/2 result in an increased risk of CV disease
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Initial diagnosis of Breast Cancer in 2005 or later BRCA testing documenting either germline mutation in BRCA1/BRCA2 or no mutation in BRCA1/2.
Condition
  • Breast Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Heart Diseases
  • Drug-Induced Cardiomyopathy
Intervention
  • Diagnostic Test: echocardiography
    Resting echocardiograms (Vivid E9 or E95, GE Healthcare) with conventional measures of systolic and diastolic function, in conjunction with posthoc quantitation of novel measures of strain and strain rate will be obtained at each study time point.
  • Other: Cardiopulmonary Exercise Testing
    A cardiopulmonary exercise test (CPET, also called V02 test) will be completed at each study time point utilizing a standard clinical protocol, on either a stationary bike or treadmill. The purpose of this test is to estimate maximal oxygen consumption (V02 max) as in index of cardiopulmonary fitness. Resting ECG, heart rate, and BP will be obtained prior to beginning the test, during each stage of the test and for 5 minutes after the test is stopped.
  • Other: Blood Collection
    We will obtain blood samples (approximately 16mL) at baseline and (approximately 12mL) at each follow-up visit. Typically these will be drawn via peripheral venipuncture, however if patients have a port-a-cath in place, blood may be drawn from the port instead.
Study Groups/Cohorts
  • Group 1
    Subjects with genetic testing confirming deleterious mutations in BRCA1 or BRCA2 whose prior treatment for breast cancer includes anthracycline exposure. All groups have same schedule of study procedures, including echocardiography, cardiopulmonary exercise testing, and blood collection.
    Interventions:
    • Diagnostic Test: echocardiography
    • Other: Cardiopulmonary Exercise Testing
    • Other: Blood Collection
  • Group 2
    Subjects with genetic testing confirming deleterious mutations in BRCA1 or BRCA2 whose prior treatment for breast cancer does not include anthracycline exposure. All groups have same schedule of study procedures, including echocardiography, cardiopulmonary exercise testing, and blood collection.
    Interventions:
    • Diagnostic Test: echocardiography
    • Other: Cardiopulmonary Exercise Testing
    • Other: Blood Collection
  • Group 3
    Subjects with genetic testing confirming no mutation in BRCA1 or BRCA2 whose prior treatment for breast cancer includes anthracycline exposure. All groups have same schedule of study procedures, including echocardiography, cardiopulmonary exercise testing, and blood collection.
    Interventions:
    • Diagnostic Test: echocardiography
    • Other: Cardiopulmonary Exercise Testing
    • Other: Blood Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 12, 2020)
79
Original Estimated Enrollment
 (submitted: April 18, 2018)
100
Estimated Study Completion Date April 2024
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age
  • Initial diagnosis of Breast Cancer in 2005 or later
  • Documented BRCA testing (results from a local laboratory are acceptable) showing

    • confirmation of a germline mutation in BRCA1 or BRCA2 that is predicted or suspected to be deleterious OR
    • confirmation that no mutation was detected in BRCA1 or BRCA2
  • Non-carriers will have been treated with an anthracycline-based chemotherapy regimen; carriers may or may not have been treated with an anthracycline-based chemotherapy regimen.
  • Approximately at least 12 months from initiation of adjuvant treatment or neo-adjuvant chemotherapy
  • Able to provide informed consent

Exclusion Criteria

  • Stage IV Breast Cancer
  • Genetic testing confirming a variant of unknown significance (VUS) or benign polymorphism in BRCA1 or BRCA2
  • V02 Testing contraindicated for any reason, including:

    • Myocardial infarction (within past 3 months)
    • High-risk unstable angina;
    • High-risk or uncontrolled cardiac arrhythmias;
    • Symptomatic severe aortic stenosis;
    • Uncontrolled symptomatic heart failure;
    • Acute pulmonary embolus or pulmonary infarction;
    • Acute myocarditis or pericarditis;
    • Acute aortic dissection;
    • Coronary revascularization procedure within the past three months;
    • Uncontrolled hypertension, defined as systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg;
    • Clinically significant valvular heart disease (severe stenosis or regurgitation);
    • Known aortic aneurysm; or
    • Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the V02 test
  • Women who are pregnant
  • Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03510689
Other Study ID Numbers UPCC 13117
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Bonnie Ky, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date October 2020