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Trial record 3 of 3 for:    NCT02603341

Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Ancillary Study

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ClinicalTrials.gov Identifier: NCT04361240
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This is an ancillary study to the "Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients with non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial" (NCT02603341). The investigators will collect cardiovascular (CV) biomarkers and echocardiograms prior to, during, and for up to 1 year following radiation for a subset of patients enrolled on RadComp and to evaluate the impact of proton vs photon radiation therapy (RT) on CV function and structure.

Condition or disease Intervention/treatment
Breast Cancer Cardiotoxicity Radiation: Proton vs Photon Radiation

Detailed Description:
The study population of the ancillary study will consist of newly enrolled RadComp trial participants. Patients on this ancillary will be consented prior to RadComp randomization to decrease the bias secondary to RT type and enhance internal validity. The study will define the early changes in biomarkers, imaging measures, and RT dose volume metrics and long-term (5-10 year) CV clinical outcomes using the RadComp parent study's infrastructure for clinical data collection and long-term follow-up. Blood samples, echocardiograms, and questionnaires are obtained at baseline (between end of chemotherapy and start of RT), immediately after the end of RT, and at 6 months and 12 months after the end of RT. An additional blood sample will be collected at 4 weeks after the start of RT. Clinical, demographic, and patient reported outcomes data are collected as part of the RadComp parent study. In addition to data collected by RadComp, we will collect a limited set of clinical data and two additional quality of life instruments for the ancillary study.

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Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Ancillary Cohort Study
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Ancillary Cohort
No Intervention: Subjects will be followed before, during and for up to 1 year after radiation with echocardiogram, blood draw, and symptoms and activity survey.
Radiation: Proton vs Photon Radiation
Assignment to proton vs photon by randomization on RadComp parent study.




Primary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF) [ Time Frame: 14 months ]
    Change in echocardiography derived LVEF from baseline

  2. Right Ventricular (RV) Fractional Area Change (FAC) [ Time Frame: 14 months ]
    Change in echocardiography derived RV FAC from baseline

  3. Circulating N-terminal pro B-type natriuretic peptide (NTproBNP) [ Time Frame: 14 months ]
    Change in NTproBNP levels from baseline

  4. Circulating Placental Growth Factor (PIGF) [ Time Frame: 14 months ]
    Change in PIGF levels from baseline

  5. Circulating Growth Differentiation Factor-15 (GDF-15) [ Time Frame: 14 months ]
    Change in GDF-15 levels from baseline


Secondary Outcome Measures :
  1. LV systolic strain [ Time Frame: 14 months ]
    Change in 2D echocardiography derived LV global longitudinal strain and circumferential strain from baseline

  2. Echocardiography derived Ventricular Arterial Coupling Measurement [ Time Frame: 14 months ]
    Change from baseline in ventricular arterial coupling as defined by end systolic elastance divided by effective arterial elastance

  3. Diastolic function (E/e') [ Time Frame: 14 months ]
    Change in E/e' from baseline as measured by echocardiogram

  4. Circulating Troponin T(TnT) [ Time Frame: 14 months ]
    Change in high-sensitivity TnT levels from baseline

  5. Circulating high-sensitivity C-Reactive Protein (hsCRP) [ Time Frame: 14 months ]
    Change in hsCRP levels from baseline


Other Outcome Measures:
  1. 3D LVEF [ Time Frame: 14 months ]
    Change in 3d echocardiography derived LVEF from baseline

  2. 3D LV systolic strain [ Time Frame: 14 months ]
    Change in 3D echocardiography derived longitudinal and circumferential strain from baseline

  3. LV Twist and Torsion [ Time Frame: 14 months ]
    Change in 3D echocardiography derived measures of LV twist and torsion from baseline

  4. Patient Reported Outcomes (PRO) Common Terms and Criteria for Adverse Events (CTCAE) [ Time Frame: 14 months ]
    Incidence and severity of PRO CTCAEs

  5. Incidence of major cardiovascular events (MCE) [ Time Frame: 10 years ]
    Collected, defined, and adjudicated by the RadComp study team


Biospecimen Retention:   Samples With DNA
Plasma, Serum, and Buffy coat are collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible for and enrolling on the RadComp trial at participating RadComp sites will be approached for the ancillary cohort.
Criteria

Inclusion Criteria:

  • Consented to RadComp
  • Willing and able to provide written consent

Exclusion Criteria:

  • Knowledge of randomization on RadComp prior to enrollment on ancillary study
  • Non-diagnostic echocardiography windows as assessed on local read.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361240


Contacts
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Contact: Bonnie Ky, MD, MSCE 215-573-6606 bonnie.ky@pennmedicine.upenn.edu
Contact: Laney Smith, MA 215-615-3245 amanda.smith4@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Bonnie Ky, MD, MSCE    215-573-6606      
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Bonnie Ky, MD, MSCE University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04361240    
Other Study ID Numbers: UPCC 17119
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Participants may opt in to allowing data and/or banked samples to be used for future research and shared with other researchers. A detailed plan for sharing IPD will be finalized at a later date, and may depend in part on how many participants elect this option. Additional supporting information may be shared, including the study protocol and informed consent form.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Cardio-Oncology
Radiation Therapy Cardiotoxicity
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries