This grant is for conducting clinical studies to investigate cMLC-1 as a potential early biomarker for trastuzumab-induced cardiotoxicity. The primary purpose is to establish a quantitative assay for human cMLC-1 and evaluate its predictive value in a pilot study. This involves comparing cMLC-1 levels in five patients who developed cardiotoxicity (defined by a >10% decrease in left ventricular ejection fraction to <55% per CREC criteria) against five matched patients who did not. Women in the study were monitored for 15 months. Archived plasma samples will be analyzed for cMLC-1 and troponin I (as a control) collected at various time points. This research aims to identify an effective early predictor to mitigate cardiotoxic effects associated with trastuzumab therapy.
Opportunity ID: 294016
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-17-006 |
| Funding Opportunity Title: | Developing Biomarkers for Trastuzumab-induced Cardiotoxicity |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | May 22, 2017 |
| Last Updated Date: | Jul 20, 2017 |
| Original Closing Date for Applications: | Jul 24, 2017 |
| Current Closing Date for Applications: | Jul 24, 2017 |
| Archive Date: | Aug 23, 2017 |
| Estimated Total Program Funding: | $140,000 |
| Award Ceiling: | $140,000 |
| Award Floor: | $140,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | FOA |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone( 240)402-7592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Revised expiration date to 7/24/2017 | Jul 20, 2017 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-17-006 |
| Funding Opportunity Title: | Developing Biomarkers for Trastuzumab-induced Cardiotoxicity |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | May 22, 2017 |
| Last Updated Date: | Jul 20, 2017 |
| Original Closing Date for Applications: | Jul 24, 2017 |
| Current Closing Date for Applications: | Jul 24, 2017 |
| Archive Date: | Aug 23, 2017 |
| Estimated Total Program Funding: | $140,000 |
| Award Ceiling: | $140,000 |
| Award Floor: | $140,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | FOA |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone( 240)402-7592 Email:shashi.malhotra@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone( 240)402-7592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00232709 | May 23, 2017 | Jul 24, 2017 | View |
Package 1
Mandatory forms
294016 RR_SF424_2_0-2.0.pdf
294016 PHS398_CoverPageSupplement_3_0-3.0.pdf
294016 RR_OtherProjectInfo_1_3-1.3.pdf
294016 PerformanceSite_2_0-2.0.pdf
294016 RR_KeyPersonExpanded_2_0-2.0.pdf
294016 RR_Budget_1_3-1.3.pdf
294016 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
294016 RR_SubawardBudget30_1_3-1.3.pdf
294016 PHS_Inclusion_Enrollment_Report-1.0.pdf
294016 PHS_AssignmentRequestForm-1.0.pdf
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