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SELENIUM BASED CHEMOPREVENTION - HGPIN

Award Number: U01CA077178
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/1998
PERIOD OF PERFORMANCE END DATE: 07/31/2010

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SELENIUM BASED CHEMOPREVENTION - HGPIN - DESCRIPTION (provided by applicant): The clinical trial reported in 1996 by Dr. Larry Clark provided strong, human-based evidence that selenium supplementation protects against prostate cancer. Continued follow-up of Dr. Clark's study group (by JRM), continues to indicate a statistically significant, though slightly diminished, decrease in risk with selenium supplementation. While these results are encouraging, prostate cancer was only one of several endpoints considered by Dr. Clark, and the people he studied were nonmelanoma skin cancer patients living in a region with extremely low forage selenium levels. Clearly, Dr. Clark's work demands follow-up. We propose to complete our randomized clinical trial of selenium among men who, by virtue of having been diagnosed with high-grade prostatic intraepithelial neoplasia, are at substantially increased risk of prostate cancer. Each subject at baseline receives a biopsy that, to the degree practicable, minimizes the probability of undiagnosed cancer, and each subject is designated to receive a 3-year follow-up biopsy. Biopsy data is reviewed centrally by a prostate pathologist (WS), who is a leader in HGPIN research. To date, over 280 men have been registered, and 200 have been randomized toward our study goal of 465 randomizations. The primary study endpoint is PC, identified by sextant or greater prostatic biopsy. The second endpoint is toxicity, identified by patient symptom report. We have experienced difficulty obtaining sample blocks adequate for Ki-67 and TUNEL analysis of proliferation and apoptosis, respectively, but will have completed developmental evaluation of these secondary endpoint biomarkers by the end of the present study period. We intend to write a separate proposal for support of additional analyses of those markers. We propose to continue our machine vision analysis of the degradation of the basal cell layer of prostatic ducts and glands and of nuclear chromatin patterns in secretory cell nuclei. This study promises to be the largest and most methodologically rigorous to date of HGPIN, which is widely believed to be the key premalignant lesion for prostate cancer.


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: 2010 ( Subtotal = $0 )
2010	2008	HEALTH RESEARCH, INC - ROSWELL PARK DIVISION	666 ELM STREET	BUFFALO	NY	14203	ERIE	USA	Cancer Control	000	13	3/30/2010	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2009 ( Subtotal = $0 )
2009	2008	HEALTH RESEARCH, INC - ROSWELL PARK DIVISION	666 ELM STREET	BUFFALO	NY	14203	ERIE	USA	Cancer Control	001	13	12/19/2008	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2009	2008	HEALTH RESEARCH, INC - ROSWELL PARK DIVISION	666 ELM STREET	BUFFALO	NY	14203	ERIE	USA	Cancer Control	002	13	7/14/2009	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2009	2007	UNIVERSITY OF TEXAS HEALTH SCIENCE CTR AT SAN ANTONIO	7703 FLOYD CURL DRIVE	SAN ANTONIO	TX	78284	BEXAR	USA	Cancer Control	000	12	6/9/2009	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2008 ( Subtotal = $309,798 )
2008	2008	HEALTH RESEARCH, INC - ROSWELL PARK DIVISION	666 ELM STREET	BUFFALO	NY	14203	ERIE	USA	Cancer Control	000	13	9/23/2008	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$309,798
														Subtotal = $309,798

Issue Date FY: 2007 ( Subtotal = $1 )
2007	2007	CANCER THERAPY & RESEARCH CENTER	7979 WURZBACH URSCHEL TOWER	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	11	8/24/2007	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2006 ( Subtotal = $0 )
2006	2006	CANCER THERAPY & RESEARCH CENTER	7979 WURZBACH URSCHEL TOWER	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	10	9/14/2006	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2004 ( Subtotal = $0 )
2004	2004	CANCER THERAPY & RESEARCH CENTER	7979 WURZBACH URSCHEL TOWER	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	8	9/2/2004	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2003 ( Subtotal = $832,011 )
2003	2003	CTRC RESEARCH FOUNDATION	8122 DATAPOINT DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	6	9/17/2003	NON-COMPETING CONTINUATION	$832,011
														Subtotal = $832,011

Issue Date FY: 2002 ( Subtotal = $855,200 )
2002	2002	CTRC RESEARCH FOUNDATION	8122 DATAPOINT DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	5	9/26/2002	NON-COMPETING CONTINUATION	$855,200
														Subtotal = $855,200

Issue Date FY: 2001 ( Subtotal = $778,548 )
2001	2001	CTRC RESEARCH FOUNDATION	8122 DATAPOINT DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	4	9/5/2001	NON-COMPETING CONTINUATION	$778,548
														Subtotal = $778,548

Issue Date FY: 2000 ( Subtotal = $941,476 )
2000	2000	CTRC RESEARCH FOUNDATION	8122 DATAPOINT DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	3	9/25/2000	NON-COMPETING CONTINUATION	$941,476
														Subtotal = $941,476

Issue Date FY: 1999 ( Subtotal = $0 )
1999	1999	CTRC RESEARCH FOUNDATION	8122 DATAPOINT DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	2	9/23/1999	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 1998 ( Subtotal = $808,393 )
1998	1998	CTRC RESEARCH FOUNDATION	8122 DATAPOINT DRIVE	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Control	000	1	9/30/1998	NEW	$808,393
														Subtotal = $808,393

Grand Total All Awards = $4,525,427

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SELENIUM BASED CHEMOPREVENTION - HGPIN

Award Number: U01CA077178

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/30/1998

PERIOD OF PERFORMANCE END DATE: 07/31/2010

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