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Developing Biomarkers for Trastuzumab-induced Cardiotoxicity
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.
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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $140,000
Office: Food and Drug Administration
Estimated Funding: $140,000
Who's Eligible
Obtain Full Opportunity Text:
FOA
Additional Information of Eligibility:
1.
Eligible ApplicantsEligible OrganizationsHigher Education Institutions• Public/State Controlled Institutions of Higher Education • 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• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Governments• State Governments • County Governments• City or Township Governments• Special District Governments• Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized)• Eligible Agencies of the Federal Government• U. S. Territory or PossessionOther• Independent School Districts• Public Housing Authorities/Indian Housing Authorities• Native American Tribal Organizations (other than Federally recognized tribal governments)• Faith-based or Community-based Organizations• Regional Organizations• 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.
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-17-006.html
Contact:
Shashi MalhotraGrants Management SpecialistPhone( 240)402-7592
Agency Email Description:
work
Agency Email:
shashi.malhotra@fda.hhs.gov
Date Posted:
2017-05-23
Application Due Date:
2017-07-10
Archive Date:
2017-08-23
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