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Trial record 59 of 2162 for:    doxorubicin

The Role of suPAR Biomarker in Blood Samples of Breast Cancer Patients During and Post Doxorubicin Chemotherapy: Causative vs. Predictor

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ClinicalTrials.gov Identifier: NCT03505164
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Tochukwu Okwuosa, Rush University Medical Center

Brief Summary:

This study looks to find a causative or predictive aspect of the suPAR biomarker for heart failure in breast cancer patients receiving Doxorubicin drug chemo regimen.

suPAR is a circulating protein which can be found in blood and/or urine and is associated with both kidney and heart disease.

  • Hypothesis 1: Higher suPAR at baseline will predispose to Doxorubicin-induced cardiomyopathy or heart failure, observed by histology (under the microscope and other lab techniques) in mouse models, and tested using heart ultrasound techniques in humans.
  • Hypothesis 2: suPAR is a marker of Doxorubicin-induced cardiomyopathy or heart failure after exposure to Doxorubicin, observed by histology (under the microscope and other lab techniques) in mouse models, and tested in humans.

The study will look at suPAR's association with three other biomarkers called troponin, B-Type Natriuretic Peptide (BNP) and C- Reactive Protein (CRP) that are also associated with heart disease.

In this study, the patient will have blood drawn as a routine part of the cancer treatment. That is prior to starting the cancer therapy, then after the first 2 and last 2 doxorubicin cycles (4 cycles altogether); as well as at 3, 6, & 12 months after doxorubicin treatment. (6 Visits in total) The patient will also have an echocardiogram (echo, heart ultrasound) at each of these time points. The first of the six study echos is considered part of the routine care.


Condition or disease
Doxorubicin Adverse Reaction Cardiomyopathies, Secondary Breast Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of suPAR in Doxorubicin Induced Cardiomyopathy in Breast Cancer Patients: Causative vs. Predictor
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018





Primary Outcome Measures :
  1. Causality relationship between the suPAR blood level and doxorubicin-induced cardiomyopathy [ Time Frame: 12 months ]

    A blood draw will be done at baseline for all participants. The blood samples will be processed by Centrifugation, to separate the plasma, and the suPAR level measured using ELISA technique, to stratify the participants that have a higher or normal baseline.

    Although there is no current consensus regarding normal suPAR blood level, a level of 3000 pg/mL is considered a high level.

    Higher baseline blood level of suPAR, will predispose patients with breast cancer undergoing chemo regimen containing doxorubicin, to develop heart toxicity (heart failure or cardiomyopathy).

    Heart failure or Cardiomyopathy will be diagnosed by the clinical evaluation with signs and symptoms, LVEF (Left Ventricular Ejection Fraction) with echocardiograms (heart ultrasound), and surrogate cardiovascular outcome measures as described in humans, and tissue visualization and histology in mouse models, with various staining techniques, whether it was H&E staining, or other immunological staining.


  2. Predictive relationship between suPAR blood level and doxorubicin-induced cardiomyopathy [ Time Frame: 12 months ]

    A blood draw will be done at baseline for all participants. The blood samples will be processed by Centrifugation to separate the plasma, and the suPAR level measured using ELISA technique, to stratify the participants having a higher or normal baseline.

    Although there is no current consensus regarding normal suPAR blood level, a level less than 3000 pg/mL is considered a normal level.

    A normal baseline blood level of suPAR, with progressive elevation following doxorubicin exposure, along with other blood markers for heart failure, will be considered as a predictive marker for doxorubicin-induced cardiomyopathy.

    Heart failure or Cardiomyopathy will be diagnosed by the clinical evaluation with signs and symptoms, LVEF (Left Ventricular Ejection Fraction) with echocardiograms (heart ultrasound), and surrogate cardiovascular outcome measures as described in humans, and tissue visualization and histology in mouse models using H&E staining, or other immunological staining techniques.



Biospecimen Retention:   Samples Without DNA
Blood samples are put in a Centrifugation machine to separate the plasma. The plasma is then kept in -70 to -80 degrees Fahrenheit. Each sample will be studied for suPAR levels.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Female patients aged between 18 and 64, recently diagnosed with non metastatic breast cancer, and will be receiving doxorubicin containing chemo regimen.

All patients are being treated at Rush University Medical Center, Chicago, IL, and Rush Oak Park Hospital, Oak Park, IL.

Criteria

Inclusion Criteria:

  • 18 - 64 years
  • Undergoing chemotherapy in the Rush cancer center with a plan for doxorubicin (Adriamycin®) chemotherapy.

Exclusion Criteria:

  • Patients with metastatic breast cancer - complicated chemotherapy regimens, higher mortality risk
  • HER2 positive breast cancer patients planned for trastuzumab therapy
  • Patients with baseline cardiomyopathy (reduced LVEF: less than 50%)
  • Patients with prior cardiovascular history of myocardial infarction (MI), angina, Congestive Heart Disease (CHD) death, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) including percutaneous transluminal coronary angioplasty (PTCA) and end-stage renal disease (ESRD), atrial fibrillation prior to cancer diagnosis
  • Atrial fibrillation noted on baseline ECG

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): NCT03505164


Contacts
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Contact: Tochi Okwuosa, DO, FACC 312-942-4601 ext 9610 tokwuosa@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Tochi Okwuosa, DO, FACC    312-942-4601 ext 9610    tokwuosa@rush.edu   
Principal Investigator: Tochi Okwuosa, DO, FACC         
Sub-Investigator: Kathrin Banach, PhD         
Sub-Investigator: Changli Wei, PhD         
Rush Oak Park Hospital Recruiting
Oak Park, Illinois, United States, 60304
Contact: Tochi Okwuosa, DO, FACC    312-942-4601 ext 9610    tokwuosa@rush.edu   
Principal Investigator: Tochi Okwuosa, DO, FACC         
Sub-Investigator: Kathrin Banach, PhD         
Sub-Investigator: Changli Wei, PhD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Tochi Okwuosa, DO, FACC Rush University Medical Center

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Responsible Party: Tochukwu Okwuosa, Tochukwu M. Okwuosa, DO, FACC, Assistant Professor of Medicine and Cardiology, Director of Cardio-Onc Services, Principal Investigator in the suPAR pilot study., Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03505164     History of Changes
Other Study ID Numbers: 16022426
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Tochukwu Okwuosa, Rush University Medical Center:
Doxorubicin
suPAR
Caridomyopathy
Heart Failure
Breast Cancer
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Breast Neoplasms
Cardiomyopathies
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Heart Diseases
Cardiovascular Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action