OpportunityTitle: Developing Biomarkers for Trastuzumab-induced Cardiotoxicity
AdditionalInformationOnEligibility: 1. Eligible ApplicantsEligible OrganizationsHigher Education Institutions&#8226; Public/State Controlled Institutions of Higher Education &#8226; Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education&#8226; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) &#8226; Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations&#8226; Small Businesses&#8226; For-Profit Organizations (Other than Small Businesses)Governments&#8226; State Governments &#8226; County Governments&#8226; City or Township Governments&#8226; Special District Governments&#8226; Indian/Native American Tribal Governments (Federally Recognized) &#8226; Indian/Native American Tribal Governments (Other than Federally Recognized)&#8226; Eligible Agencies of the Federal Government&#8226; U.S. Territory or PossessionOther&#8226; Independent School Districts&#8226; Public Housing Authorities/Indian Housing Authorities&#8226; Native American Tribal Organizations (other than Federally recognized tribal governments)&#8226; Faith-based or Community-based Organizations&#8226; Regional Organizations&#8226; Non-domestic (non-U.S.) Entities (Foreign Institutions)  Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
Description: This award is intended to provide support to conduct clinical studies at a clinical site with capability and patients samples to investigate potential biomarker (cMLC1) for trastuzumab-induced cardiotoxicity. 1) There will be an establishment of the assay to quantitatively measure cMLC-1 in humans. 2) Investigations will be conducted to determine the value of cMLC-1 in humans as an early predictor of cardiotoxicity in a pilot study. A comparison will be done of the level of cMLC-1 in 5 patients who subsequently developed cardiotoxicity and 5 patients who did not. Patients will be matched for age. Cardiotoxicity was defined using the Cardiac Review and Evaluation Committee for Trastuzumab (CREC) criteria as a decrease of more than 10% in the echocardiographic left ventricular ejection fraction to a value of less than 55%. 3) Women were monitored every 3 months for 15 months. 4) The archived plasma samples collected at multiple time points indicated below schematically will be tested for the biomarker cMLC-1 and for troponin I, an established marker for heart muscle damage as a control.
GrantorContactEmailDescription: work
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone( 240)402-7592