Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Cardiomyopathies, Secondary Doxorubicin Adverse Reaction

Keywords

DoxorubicinsuPARCardiomyopathyHeart FailureBreast Cancer

Outcome Measures

Primary Outcomes (2)

Causality relationship between the suPAR blood level and doxorubicin-induced cardiomyopathy
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.
12 months
Predictive relationship between suPAR blood level and doxorubicin-induced cardiomyopathy
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.

Eligibility Criteria

Age18 Years - 64 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodProbability 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.

You may qualify if:

years

Sponsors & Collaborators

Rush University Medical Center
Otherlead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Rush Oak Park Hospital

Oak Park, Illinois, 60304, United States

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.

MeSH Terms

Conditions

CardiomyopathiesBreast NeoplasmsHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Tochi Okwuosa, DO, FACC
Rush University Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Tochukwu M. Okwuosa, DO, FACC, Assistant Professor of Medicine and Cardiology, Director of Cardio-Onc Services, Principal Investigator in the suPAR pilot study.

Study Record Dates

First Submitted

August 31, 2017

First Posted

April 23, 2018

Study Start

January 17, 2017

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations