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.
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| AWARD OVERVIEW |
| Award Number |
1RC2CA148572-01 |
Funding Agency |
Department of Health and Human Services |
| Total Award Amount |
$1,649,791 |
Project Location - City |
TOLEDO |
| Award Date |
09/30/2009 |
Project Location - State |
OH |
| Project Status |
More than 50% Completed |
Project Location - Zip |
43614-2595
|
| Jobs Reported |
4.52 |
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 |
More than 50% Completed |
| Final Project Report Submitted |
No |
| Project Activities Description |
Cancer |
| Quarterly Activities/Project Description |
Project Description: 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. Quarterly activities: We have enrolled 384 subjects across sites. In addition, we have enrolled 16 CPORT (lung cancer) subjects. Enrollment of CPORT subjects will facilitate optimization of cut-points for the LCRT. We expect to enroll the necessary CPORT subjects and complete cut-point analysis by end of second quarter 2013. Before LCRT funding ends in second quarter of 2013, we will enroll as many LCRT subjects as possible into the LC-COPD study, funded by HL108016, which provides for annual follow-up. We will continue to follow the LCRT subjects at least through completion of HL108016 funding in second quarter of 2015 and likely through second quarter of 2016 on a no-cost extension. This will provide follow-up of from 4-6 years for each of the LCRT subjects. Because the reported lung cancer incidence rate in a similar population was 3.1%/3.9 years, we expect to observe 15 lung cancers by second quarter of 2016. No serious adverse events have been attributed to the study. We submitted an abstract for presentation at 2013 ATS including an update of LCRT cohort demographics. |
| Jobs Created |
4.52 |
| Description of Jobs Created |
To date 31 positions have been hired or retained at 12 clinical sites and one laboratory site. Mayo Clinic Rochester has created or retained 2 positions including a .50 FTE Study Coordinator position and .05 FTE for their Principal Investigator. Henry Ford Health Systems has created or retained 6 positions, 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 retained one position, a .50 FTE Project Manager. UT has created or retained 5 jobs, 0.5 FTE for a laboratory technician, 0.5 FTE for a Clinical Coordinator, 0.3 FTE for PI, 0.3 FTE for a Project Manager, and 0.3FTE for Project Administrator. Tennessee VA has created or retained 2 jobs. Toledo Hospital has retained 2 jobs including a Project Manager and a Clinical Coordinator. Cleveland Clinic has hired or retained 2 positions, a clinical coordinator and a lab technician; Inova/Fairfax Hospital has hired or retained one position, a clinical coordinator; National Jewish Hospital has hired or retained three positions, two clinical coordinators and a lab technician; the University of Michigan has created or retained 2 positions, a clinical coordinator and a lab technician; Ohio State University has hired or retained 2 positions, two clinical coordinators; Vanderbilt University Medical Center has hired or retained three positions, a two clinical coordinators and a lab tech. Medical University of South Carolina has created a .5 FTE research assistant position. |
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 |
1RC2CA148572-01 |
| 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 |
$1,649,791 |
| Funds Invoiced/Received |
$1,637,494 |
| Expenditure Amount |
$1,649,791 |
| 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 |
14 |
| Sub-award Amounts to Organizations |
$2,067,091 |
| 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 |
1 |
| Total Amount of payments to vendors greater than $25,000/award |
$36,374 |
| Number of payments to vendors less than $25,000/award |
46 |
| Total Amount of payments to vendors less than $25,000/award |
$10,454 |
Sub-award Accugenomics N 2012-092 - ACCUGENOMICS
| Sub-Award Amount |
$115,425 |
| Sub-Award Date |
09/07/2011 |
| Sub-Awards Disbursed |
$99,981.60 |
| Project Location - City |
Wilmington |
| Project Location - State |
NC |
| Project Location - Zip Code |
28403-5502 |
| Project Location - Congressional District |
07 |
| Sub-Recipient DUNS Number |
966640026
|
| Sub-Recipient Address |
1410 COMMONWEALTH DR STE 105 |
| Sub-Recipient City |
WILMINGTON |
| Sub-Recipient State |
North Carolina |
| Sub-Recipient Zip Code |
28403-0376 |
| Sub-Recipient Congressional District |
07 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award Cleveland NS 2011-60 - CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU
| Sub-Award Amount |
$73,250 |
| Sub-Award Date |
09/30/2009 |
| Sub-Awards Disbursed |
$47,512.00 |
| Project Location - City |
Cleveland |
| Project Location - State |
OH |
| Project Location - Zip Code |
44195-0001 |
| Project Location - Congressional District |
11 |
| Sub-Recipient DUNS Number |
135781701
|
| Sub-Recipient Address |
9500 EUCLID AVE |
| Sub-Recipient City |
CLEVELAND |
| Sub-Recipient State |
Ohio |
| Sub-Recipient Zip Code |
44195-0001 |
| Sub-Recipient Congressional District |
11 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award HFHS NS 2010-23 - HENRY FORD HEALTH SYSTEM
| Sub-Award Amount |
$398,139 |
| Sub-Award Date |
02/24/2010 |
| Sub-Awards Disbursed |
$398,139.44 |
| 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 PLACE |
| 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 I.D. Clinical Rsch NS2012-103 - I D CLINICAL RESEARCH LTD
| Sub-Award Amount |
$114,500 |
| Sub-Award Date |
09/30/2011 |
| Sub-Awards Disbursed |
$17,050.00 |
| Project Location - City |
Toledo |
| Project Location - State |
OH |
| Project Location - Zip Code |
43608-2671 |
| Project Location - Congressional District |
09 |
| Sub-Recipient DUNS Number |
036573226
|
| Sub-Recipient Address |
2409 CHERRY ST STE 203 |
| Sub-Recipient City |
TOLEDO |
| Sub-Recipient State |
OH |
| Sub-Recipient Zip Code |
43608 |
| Sub-Recipient Congressional District |
09 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award Inova NS 2011-81 - INOVA HEALTH CARE SERVICES
| Sub-Award Amount |
$36,400 |
| Sub-Award Date |
07/05/2011 |
| Sub-Awards Disbursed |
$12,859.00 |
| Project Location - City |
Falls Church |
| Project Location - State |
VA |
| Project Location - Zip Code |
22042-1252 |
| Project Location - Congressional District |
11 |
| Sub-Recipient DUNS Number |
054427455
|
| Sub-Recipient Address |
8110 GATEHOUSE RD STE 200 E |
| Sub-Recipient City |
FALLS CHURCH |
| Sub-Recipient State |
Virginia |
| Sub-Recipient Zip Code |
22042-1252 |
| Sub-Recipient Congressional District |
11 |
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 |
$50,165.00 |
| 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 Medical University of South Carolina NS2011-73 - MEDICAL UNIVERSITY OF SOUTH CAROLINA
| Sub-Award Amount |
$155,000 |
| Sub-Award Date |
02/09/2012 |
| Sub-Awards Disbursed |
$55,000.00 |
| Project Location - City |
Charleston |
| Project Location - State |
SC |
| Project Location - Zip Code |
29425-8900 |
| Project Location - Congressional District |
06 |
| Sub-Recipient DUNS Number |
183710748
|
| Sub-Recipient Address |
179 ASHLEY AVE |
| Sub-Recipient City |
CHARLESTON |
| Sub-Recipient State |
South Carolina |
| Sub-Recipient Zip Code |
29425-8908 |
| Sub-Recipient Congressional District |
06 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award VA Tenn NS 2010-06 - MIDDLE TENNESSEE RESEARCH INSTITUTE
| Sub-Award Amount |
$85,250 |
| Sub-Award Date |
06/03/2010 |
| Sub-Awards Disbursed |
$9,597.00 |
| Project Location - City |
Nashville |
| Project Location - State |
TN |
| Project Location - Zip Code |
37212-2637 |
| Project Location - Congressional District |
05 |
| Sub-Recipient DUNS Number |
111010943
|
| Sub-Recipient Address |
1310 24TH AVE S RM F 201 |
| Sub-Recipient City |
NASHVILLE |
| Sub-Recipient State |
Tennessee |
| Sub-Recipient Zip Code |
37212-2637 |
| Sub-Recipient Congressional District |
05 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award National Jewish Health NS02012-93 - NATIONAL JEWISH HEALTH
| Sub-Award Amount |
$72,800 |
| Sub-Award Date |
02/12/2012 |
| Sub-Awards Disbursed |
$5,430.00 |
| Project Location - City |
Denver |
| Project Location - State |
CO |
| Project Location - Zip Code |
80206-2761 |
| Project Location - Congressional District |
01 |
| Sub-Recipient DUNS Number |
076443019
|
| Sub-Recipient Address |
1400 JACKSON ST |
| Sub-Recipient City |
DENVER |
| Sub-Recipient State |
Colorado |
| Sub-Recipient Zip Code |
80206-2761 |
| 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 |
$37,176.00 |
| Project Location - City |
Columbus |
| Project Location - State |
OH |
| Project Location - Zip Code |
43210-1016 |
| Project Location - Congressional District |
03 |
| 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 |
03 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award UofM NS 2010-26 - REGENTS OF THE UNIVERSITY OF MICHIGAN
| Sub-Award Amount |
$260,000 |
| Sub-Award Date |
01/28/2010 |
| Sub-Awards Disbursed |
$260,000.00 |
| Project Location - City |
Ann Arbor |
| Project Location - State |
MI |
| Project Location - Zip Code |
48109-1274 |
| Project Location - Congressional District |
12 |
| 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 |
12 |
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 |
$109,353.60 |
| Project Location - City |
Irvine |
| Project Location - State |
CA |
| Project Location - Zip Code |
92618-1622 |
| Project Location - Congressional District |
45 |
| 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 |
45 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award Vanderbilt NS 2010-22 - THE VANDERBILT UNIVERSITY
| Sub-Award Amount |
$85,250 |
| Sub-Award Date |
04/20/2010 |
| Sub-Awards Disbursed |
$24,605.00 |
| Project Location - City |
Nashville |
| Project Location - State |
TN |
| Project Location - Zip Code |
37203-6869 |
| Project Location - Congressional District |
05 |
| Sub-Recipient DUNS Number |
004413456
|
| Sub-Recipient Address |
3319 WEST END AVE STE 800 |
| Sub-Recipient City |
NASHVILLE |
| Sub-Recipient State |
Tennessee |
| Sub-Recipient Zip Code |
37203-6876 |
| Sub-Recipient Congressional District |
05 |
Required To Report Top 5 Highly Compensated Officials |
No |
Sub-award Toledo NS 2011-15 - TOLEDO HOSPITAL, THE
| Sub-Award Amount |
$69,600 |
| Sub-Award Date |
09/30/2009 |
| Sub-Awards Disbursed |
$22,440.00 |
| Project Location - City |
Toledo |
| Project Location - State |
OH |
| Project Location - Zip Code |
43606-3895 |
| Project Location - Congressional District |
09 |
| Sub-Recipient DUNS Number |
054169354
|
| Sub-Recipient Address |
2142 N COVE BLVD |
| Sub-Recipient City |
TOLEDO |
| Sub-Recipient State |
Ohio |
| Sub-Recipient Zip Code |
43606-3896 |
| Sub-Recipient Congressional District |
09 |
Required To Report Top 5 Highly Compensated Officials |
No |
TIP Capital - Award Number 1RC2CA148572-01 - TIP Capital
| Award Number |
1RC2CA148572-01 |
| Sub-Award Number |
Accugenomics N 2012-092 |
| Vendor DUNS Number |
Not reported |
| Vendor HQ Zip Code + 4 |
48304-5127 |
| Vendor Name |
TIP Capital |
| Product and Service Description |
Not reported |
| Payment Amount |
$36,374 |
| 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 |
|
 |