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Predictive Epigenomic Biomarkers In Rectal Cancer Patients Receiving Treatment

Award Number: R01CA171767
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2013
PERIOD OF PERFORMANCE END DATE: 03/31/2019

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Predictive Epigenomic Biomarkers In Rectal Cancer Patients Receiving Treatment - DESCRIPTION (provided by applicant): To this day, primary rectal cancer patient management continues to be challenged by significant problems in morbidity, locoregional recurrence, and distant organ recurrence. In most studies, rectal cancer is commingled with colon cancer, yet it is clinically treated differently and molecularly distinct. Development and verification of predictive biomarkers of primary rectal tumors could significantly improve disease outcome, reduce morbidity, and most importantly improve primary rectal tumor treatment stratification. We have identified, in preliminary pilot studies, epigenomic aberrations (promoter region methylation) of non-coding genomic repeat sequences and tumor-related genes in primary rectal adenocarcinoma that are predictive biomarkers for locoregional and distant organ metastasis recurrence and disease outcome. We propose to validate these findings in primary rectal tumors from two large-scale multicenter phase III clinical trials of patients randomized between Total Mesorectal Excision surgery(TME) versus Pre-Radiotherapy followed by TME (PRTME) in a 13 yr follow-up (retrospective study), and the prospective randomized Phase III multicenter RAPIDO clinical trial of neoadjuvant chemoradiation followed by TME. Development of rectal cancer biomarkers may improve stratification into more efficient control of primary rectal tumors with and without micrometastasis. Our objective is to develop and validate a predictive biomarker panel for utility in stratifying patients for treatment. We will identify primry rectal cancer patients who could benefit from TME alone versus different approaches of neoadjuvant treatments that include radiation alone or chemoradiation regimens. The Aims are as follows: Aim I: Validate epigenomic biomarkers of primary rectal cancer to predict distant organ recurrence in TME or PRTME treated patients. Aim II: Validate epigenomic biomarkers of primary rectal cancer to predict locoregional recurrence in TME or PRTME treated patients. Aim III: Validate optimal epigenomic rectal cancer biomarkers to predict disease-free survival in neoadjuvant chemoradiation followed by TME. The study addresses an important treatment problem of primary rectal cancer using a novel combination of epigenomic predictive biomarkers.


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: 2020 ( Subtotal = -$6,178 )
2020	2017	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BLVD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	5	12/18/2019	NON-COMPETING CONTINUATION	-$6,178
														Subtotal = -$6,178

Issue Date FY: 2017 ( Subtotal = $382,423 )
2017	2017	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BLVD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	5	6/7/2017	NON-COMPETING CONTINUATION	$38,243
2017	2017	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BLVD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	5	3/30/2017	NON-COMPETING CONTINUATION	$344,180
														Subtotal = $382,423

Issue Date FY: 2016 ( Subtotal = $382,423 )
2016	2016	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	4	5/10/2016	EXTENSION WITH OR WITHOUT FUNDS	$382,423
														Subtotal = $382,423

Issue Date FY: 2015 ( Subtotal = $382,423 )
2015	2015	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	3	3/19/2015	NON-COMPETING CONTINUATION	$382,423
														Subtotal = $382,423

Issue Date FY: 2014 ( Subtotal = $370,950 )
2014	2014	JOHN WAYNE CANCER INSTITUTE	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	2	3/28/2014	NON-COMPETING CONTINUATION	$370,950
														Subtotal = $370,950

Issue Date FY: 2013 ( Subtotal = $382,423 )
2013	2013	JOHN WAYNE INSTITUTE FOR CANCER TREATMENT & RSCH	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	1	3/1/2013	NEW	$286,817
2013	2013	JOHN WAYNE INSTITUTE FOR CANCER TREATMENT & RSCH	2200 SANTA MONICA BOULEVARD	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	1	7/1/2013	NEW	$95,606
														Subtotal = $382,423

Grand Total All Awards = $1,894,464

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Predictive Epigenomic Biomarkers In Rectal Cancer Patients Receiving Treatment

Award Number: R01CA171767

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2013

PERIOD OF PERFORMANCE END DATE: 03/31/2019

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