UNIVERSITY OF TOLEDO, THE
This is a proposal to validate the accuracy of a multi-gene Lung Cancer Risk Test (LCRT). An accurate LCRT may be used to design more efficient lung cancer screening and/or chemoprevention studies by enabling enrollment of the highest risk individuals, resulting in lower false positives and lower trial costs. In addition, if and when a screening and/or chemoprevention method is validated, it may be used to identify the individuals most likely to benefit, resulting in lower cost and reduced likelihood of adverse events.
| AWARD OVERVIEW |
| Award Number |
RC2CA148572-1-000 |
Funding Agency |
Department of Health and Human Services |
| Total Award Amount |
$799,426 |
Project Location - City |
TOLEDO |
| Award Date |
09/30/2009 |
Project Location - State |
OH |
| Project Status |
Less Than 50% Completed |
Project Location - Zip |
43614-2595
|
| Jobs Reported |
2.18 |
Congressional District |
09 |
| Project Location - Country |
US |
|
|
Recipient Information
(Grants)
| Recipient Information (Grants) |
|
Recipient Name
|
UNIVERSITY OF TOLEDO, THE |
| Recipient DUNS Number |
807418939
|
| Recipient Address |
3000 ARLINGTON AVE |
| Recipient City |
TOLEDO |
| Recipient State |
Ohio |
| Recipient Zip |
43614-2595 |
| Recipient Congressional District |
09 |
| Recipient Country |
USA |
Required to Report Top 5
Highly Compensated Officials |
No |
Projects and Jobs Information
| Projects and Jobs Information |
| Project Title |
Validation of multi-gene test for lung cancer risk |
| Project Status |
Less Than 50% Completed |
| Final Project Report Submitted |
No |
| Project Activities Description |
Cancer |
| Quarterly Activities/Project Description |
• University of Toledo (UT) Clinical Care Center (CCC) Activities
o Approval of IRB at each Site University of Toledo (UT) staff members, serving as the Clinical Care Center (CCC) for this study, have coordinated approval of IRB at each site. Staff members at each site have prepared and submitted IRB applications, made necessary revisions, and reported to CCC. IRB application status at each site:
? UT: Approved (V3.0), waiting for IRB Approval letter
? MC: Initially Approved. Submitted Amendment V3.0 of protocol, awaiting approval
? HFHS: Initially Approved. Submitted Amendment V3.0 of protocol, awaiting approval
? VUMC: Approved (V3.0). IRB Approved on 3/19/10
? UM: Submitted V3.0 to IRB on 4/5/10. Awaiting IRB response
? OSU: Submitted V3.0 to IRB on 4/5/10. Awaiting IRB response
o Assembly of Regulatory Documents
? UT CCC has assembled nearly all required regulatory documents from each of the six clinical sites
o Preparation of IDE application. PI has worked closely with CCC and DCC to assemble IDE application to FDA, and respond to FDA questions as well as provide documents required by FDA toward approval of IDE
• HFHS Data Control Center (DCC) Activities
o Preparation of Data Analysis Plan is nearly complete and will be submitted to FDA by next quarterly report
o DCC worked closely with PI and CCC to provide FDA with necessary information
o DCC prepared necessary Clinical Report Files (CRFs) for data entry into Oracle Clinical (OC) database at each site, educated staff at each clinical site on use of OC
• ResearchDx Activities
o Designed and assembled the sample collection and shipping kits, Collection Cards, and Standard Operating Procedure (SOP) files to specifications of PI
o Shipped kits to each site
o Confirmed ability to receive, process, store samples
• PI Activities
o PI coordinated all of above activities, worked closely with ResearchDx, DCC, CCC, and Project Director and staff at each clinical site to educate and coordinate
|
| Jobs Created |
2.18 |
| Description of Jobs Created |
To date Mayo Clinic Rochester has created or retained 2 jobs. A .50 FTE Study Coordinator position and .05 FTE for their Principal Investigator. Henry Ford Health Systems has created or maintained a .50 FTE Research Assistant position, a .10 FTE Principal Investigator, .13 FTE for 2 Biostatisticians, .20 FTE for 2 Programmers and a .20 FTE Data Manager. ResearchDx has created or maintained a .50 FTE Project Manager. |
Purchaser Information
(Grants)
| Purchaser Information |
| Contracting Office ID |
Not Reported |
| Contracting Office Name |
Not Available |
| Contracting Office Region |
Not Available |
| TAS Major Program |
75-0850 |
| Award Information |
| Award Date |
09/30/2009 |
| Award Number |
RC2CA148572-1-000 |
| Order Number |
|
| Award Type |
Grants |
| Funding Agency ID |
75 |
| Funding Agency Name |
Department of Health and Human Services |
| Funding Office Name |
Not Available |
| Awarding Agency ID |
75 |
| Awarding Agency Name |
Department of Health and Human Services |
| Amount of Award |
$799,426 |
| Funds Invoiced/Received |
$0 |
| Expenditure Amount |
$71,691 |
| Infrastructure Expenditure Amount |
$0 |
| Infrastructure Purpose and Rationale |
Not Reported |
| Infrastructure Point of Contact Name |
Not Reported |
| Infrastructure Point of Contact Email |
Not Reported |
| Infrastructure Point of Contact Phone |
Not Reported |
| Infrastructure Point of Contact Address |
Not Reported |
| Infrastructure Point of Contact City |
Not Reported |
| Infrastructure Point of Contact State |
Not Reported |
| Infrastructure Point of Contact Zip |
Not Reported |
Product or Service Information
(Grants)
| Product or Service Information |
| Primary Activity Code |
G30 - NTEE |
| Activity Description |
Cancer |
| Sub-Awards Information |
| Sub-awards to Organizations |
5 |
| Sub-award Amounts to Organizations |
$1,176,858 |
| Sub-Awards to Individuals |
0 |
| Sub-Award Amounts to Individuals |
$0 |
| Number of Sub-awards less than $25,000/award |
0 |
| Amount of Sub-awards less than $25,000/award |
$0 |
| Number of payments to vendors greater than $25,000 |
0 |
| Total Amount of payments to vendors greater than $25,000/award |
$0 |
| Number of payments to vendors less than $25,000/award |
0 |
| Total Amount of payments to vendors less than $25,000/award |
$0 |
Sub-award HFHS NS 2010-23 - HENRY FORD HEALTH SYSTEM
| Sub-Award Amount |
$325,381 |
| Sub-Award Date |
02/24/2010 |
| Sub-Awards Disbursed |
$0.00 |
| Project Location - City |
Detroit |
| Project Location - State |
MI |
| Project Location - Zip Code |
48202-3450 |
| Project Location - Congressional District |
13 |
| Sub-Recipient DUNS Number |
073134603
|
| Sub-Recipient Address |
1 FORD PL STE 5F |
| Sub-Recipient City |
DETROIT |
| Sub-Recipient State |
Michigan |
| Sub-Recipient Zip Code |
48202-3450 |
| Sub-Recipient Congressional District |
13 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award MAYO NS 2010-25 - MAYO CLINIC
| Sub-Award Amount |
$205,254 |
| Sub-Award Date |
03/22/2010 |
| Sub-Awards Disbursed |
$0.00 |
| Project Location - City |
Rochester |
| Project Location - State |
MN |
| Project Location - Zip Code |
55905-0001 |
| Project Location - Congressional District |
01 |
| Sub-Recipient DUNS Number |
006471700
|
| Sub-Recipient Address |
200 1ST ST SW |
| Sub-Recipient City |
ROCHESTER |
| Sub-Recipient State |
Minnesota |
| Sub-Recipient Zip Code |
55905-0002 |
| Sub-Recipient Congressional District |
01 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award OSU NS 2010-24 - OHIO STATE UNIVERSITY, THE
| Sub-Award Amount |
$168,918 |
| Sub-Award Date |
01/27/2010 |
| Sub-Awards Disbursed |
$0.00 |
| Project Location - City |
Columbus |
| Project Location - State |
OH |
| Project Location - Zip Code |
43210-1016 |
| Project Location - Congressional District |
15 |
| Sub-Recipient DUNS Number |
832127323
|
| Sub-Recipient Address |
1960 KENNY RD |
| Sub-Recipient City |
COLUMBUS |
| Sub-Recipient State |
Ohio |
| Sub-Recipient Zip Code |
43210-1016 |
| Sub-Recipient Congressional District |
15 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award UofM NS 2010-26 - REGENTS OF THE UNIVERSITY OF MICHIGAN
| Sub-Award Amount |
$250,000 |
| Sub-Award Date |
01/28/2010 |
| Sub-Awards Disbursed |
$0.00 |
| Project Location - City |
Ann Arbor |
| Project Location - State |
MI |
| Project Location - Zip Code |
48109-1274 |
| Project Location - Congressional District |
15 |
| Sub-Recipient DUNS Number |
073133571
|
| Sub-Recipient Address |
503 THOMPSON ST |
| Sub-Recipient City |
ANN ARBOR |
| Sub-Recipient State |
Michigan |
| Sub-Recipient Zip Code |
48109-1340 |
| Sub-Recipient Congressional District |
15 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award ResearchDx NS 2010-XX - RESEARCHDX LLC
| Sub-Award Amount |
$227,305 |
| Sub-Award Date |
02/17/2010 |
| Sub-Awards Disbursed |
$57,000.00 |
| Project Location - City |
Irvine |
| Project Location - State |
CA |
| Project Location - Zip Code |
92618-1622 |
| Project Location - Congressional District |
48 |
| Sub-Recipient DUNS Number |
961618480
|
| Sub-Recipient Address |
13766 ALTON PKWY STE 147 |
| Sub-Recipient City |
IRVINE |
| Sub-Recipient State |
California |
| Sub-Recipient Zip Code |
92618-1622 |
| Sub-Recipient Congressional District |
48 |
Required To Report Top 5
Highly Compensated Officials |
No |
| Location Information |
| Latitude, Longitude |
41º 37' 16",
-83º 36' 54" |
| Congressional District |
09 |
| Address 1 |
3000 Arlington Avenue |
| Address 2 |
TOLEDO |
| City |
TOLEDO |
| County |
Lucas |
| State |
OH |
| Zip |
43614-2595 |
|
 |