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LACE-Bio-II: Identification, validation and implementation of prognostic and/or p

Award Number: R01CA165958
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/14/2012
PERIOD OF PERFORMANCE END DATE: 05/31/2018

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LACE-Bio-II: Identification, validation and implementation of prognostic and/or p - DESCRIPTION (provided by applicant): Investigators from the four pivotal adjuvant NSCLC trials (IALT, CALGB 9633, JBR.10, ANITA) formed the Lung Adjuvant Cisplatin Evaluation (LACE)-Bio-I consortium to conduct cross-validation/pooled meta-analyses of biomarkers that each group had identified on collected formalin fixed tumor (FFPE) to confirm their robustness/utility in a larger dataset. LACE-Bio-I had a focus predominantly on immunohistochemical methods (IHC) and single gene analyses. JBR.10 also collected fresh frozen tumor (FFT) and normal lung in a subset of patients and has identified an mRNA expression signature that is strongly prognostic and may be predictive of benefit from cisplatin/vinorelbine ACT. With the ongoing cancer genome sequencing efforts in lung cancer and the reporting of identification of novel genetic aberrations that represent crucial "oncogenic drivers" in NSCLC, we also urgently need a more adaptive strategy to explore the value of these new markers as prognostic and predictive markers in early stage patients. LACE-Bio-II has a new strategic direction. We will explore novel markers that are nucleic acid based, including gene copy number changes (amplifications and deletions), somatic gene mutations, and RNA-based markers that may involve multi-gene mRNA signatures. Using LACE-Bio FFPE tumor samples, we plan to validate the JBR.10 15-gene prognostic and predictive mRNA signature, evaluate the prognostic and predictive values of known potential oncogenic mutations, and explore the prognostic and predictive values of gene copy variations. We will also identify and evaluate the prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on snap-frozen JBR.10 samples. New high performance and sensitive technologies for assaying and quantifying genomic aberrations using nucleic acid materials derived from FFPE samples have been developed and been introduced into Clinical Laboratory Improvement Amendments (CLIA)-approved laboratories. Should our strategy be successful, identified and validated markers can be rapidly introduced into clinical practice.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	QUEEN'S UNIVERSITY AT KINGSTON	99 UNIVERSITY AVE	KINGSTON	ON	K7L 3N5		CAN	Cancer Detection and Diagnosis Research	000	5	9/5/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $502,749 )
2016	2016	QUEENS UNIVERSITY	ABRAMSKY HALL, 3RD FLOOR	KINGSTON, ONTARIO				CAN	Cancer Detection and Diagnosis Research	000	5	5/6/2016	NON-COMPETING CONTINUATION	$502,749
														Subtotal = $502,749

Issue Date FY: 2015 ( Subtotal = $499,487 )
2015	2015	QUEENS UNIVERSITY	ABRAMSKY HALL, 3RD FLOOR	KINGSTON, ONTARIO				CAN	Cancer Detection and Diagnosis Research	000	4	5/13/2015	NON-COMPETING CONTINUATION	$499,487
														Subtotal = $499,487

Issue Date FY: 2014 ( Subtotal = $431,216 )
2014	2014	QUEENS UNIVERSITY	ABRAMSKY HALL, 3RD FLOOR	KINGSTON, ONTARIO				CAN	Cancer Detection and Diagnosis Research	000	3	6/17/2014	NON-COMPETING CONTINUATION	$431,216
														Subtotal = $431,216

Issue Date FY: 2013 ( Subtotal = $417,115 )
2013	2013	QUEENS UNIVERSITY	ABRAMSKY HALL, 3RD FLOOR	KINGSTON, ONTARIO				CAN	Cancer Detection and Diagnosis Research	000	2	6/12/2013	EXTENSION WITH OR WITHOUT FUNDS	$417,115
														Subtotal = $417,115

Issue Date FY: 2012 ( Subtotal = $443,119 )
2012	2012	QUEENS UNIVERSITY	ABRAMSKY HALL, 3RD FLOOR	KINGSTON, ONTARIO				CAN	Cancer Detection and Diagnosis Research	000	1	8/14/2012	NEW	$443,119
														Subtotal = $443,119

Grand Total All Awards = $2,293,686

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LACE-Bio-II: Identification, validation and implementation of prognostic and/or p

Award Number: R01CA165958

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/14/2012

PERIOD OF PERFORMANCE END DATE: 05/31/2018

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