Updates to PAR-10-003,"Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Years 2010, 2011, and 2012 (P50)"

Notice Number: NOT-CA-11-019

Release Date: August 30, 2011

National Cancer Institute (NCI)

The purpose of this Notice is to inform the extramural research community of changes to the Program Announcement PAR-10-003, "Specialized Programs of Research Excellence (SPOREs) in Human Cancer for Years 2010, 2011, and 2012 (P50)," and the corresponding SPORE Guidelines found at http://trp.cancer.gov/.

The specific changes described herein are effective for all application due dates beginning with January 20, 2012 (until the FOA expiration date of September 21, 2012). The specific changes are:

1) Currently, "Collaborations" are one of the elements contained within "Program Organization and Capabilities (POC)". For applications submitted in 2012, "Collaborations" should be distinct from "POC". Therefore, applications for 2012 submissions will be required to provide a separate item entitled "Scientific Collaboration," up to 12 pages.

2) An "Administrative Core" (under Shared Resource Cores) will be required for applications submitted in 2012. More information on "Administrative Cores" is in the SPORE Guidelines found at http://trp.cancer.gov/.

3) Applications with a focus on certain organ sites are required to propose at least one project on early detection, prevention, screening, and/or population science; however, the list of relevant organ sites has now been reduced. For applications submitted in 2012 the list of organ sites for which this Required Project is relevant includes only breast, lung, GI and prostate.

In connection with these changes, PAR-10-003 is amended with the following text in Section IV. Application and Submission Information:

A) Subsection 2. Content and Form of Application Submission:

1) Under the heading "Program Organization and Capabilities (POC)," the third line is modified to read:

Leadership, institutional commitment, integration within the SPORE and the institution, cancer patient population, data management, and planning and evaluation activities.

2) The following text should be inserted prior to "Required Statements and Letters of Support"

Scientific Collaboration (SC)

Introduction: (Resubmission applications only) - One page limit.   

In this section of the SPORE application (12 page limit) describe collaborative efforts of SPORE projects within the SPORE community, across NCI-supported clinical trial and translational science mechanisms, and also with other government and non-government programs. Additional details regarding the content of the SC section is provided in the SPORE Guidelines (http://trp.cancer.gov/). Establishing a separate "Scientific Collaboration" fulfills a key recommendation made by the Clinical Trials and Translational Research Advisory Committee (CTAC) Guidelines Harmonization Working Group.

3) Under the heading "Shared Resource Cores," the fourth line is now replaced with the following text:

For the SPORE both a Biospecimen/Pathology Core and an Administrative Core are required. Other cores such as Biostatistics, Clinical, Bioinformatics, and Animal cores may also be proposed.

B) Subsection 6. Other Submission Requirements

1) Under the heading "Research Projects," the second bulleted paragraph is now replaced with the following text:

Each proposed research project must be designed to test the relevance and/or potential importance of the research to human cancer within the 5-year term of the grant (e.g., clinical validation of a new screening mechanism or diagnostic test, conduct of an early phase therapeutic trial, analysis of human specimens such as tumor or blood samples, and conduct of an IND-directed toxicology studies utilizing FDA-approved protocols).

2) Under the heading "Research Projects," the fourth bulleted paragraph is now replaced with the following text:

For certain organ sites (breast, lung, GI and prostate) at least ONE research project must focus on early detection, prevention, screening, and/or population science. See SPORE guidelines (http://trp.cancer.gov) for more information. For these four organ sites at least one scored project in this category will be required for award (see REVIEW CONSIDERATIONS, Section V) and must be maintained throughout the entire term of the award.

3) Under the heading "Shared Cores," the second bulleted paragraph is replaced with the following two bulleted paragraphs:

• Administrative CORE (Required). An Administrative Core section is required for the SPORE. The purpose of this CORE is to provide fiscal management, clerical support, manuscript preparation, meeting organization, data management, and quality control and communication aspects within the SPORE.
• Other COREs (Optional). Additional shared COREs (e.g., clinical, biostatistical, animal, etc.) may also be proposed that are supportive of one or more of the research projects of the SPORE. These COREs should provide essential services to at least one SPORE project and may also include other analytical or non-hypothesis driven research activities designed to enhance a service.

All other aspects of this FOA remain the same.

Please direct all inquiries to:

Toby T. Hecht, Ph.D.
Acting Associate Director
Translational Research Program (TRP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6116 Executive Boulevard, Suite 700, MSC 8347
Bethesda, MD 20892-8347 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS express/courier delivery)
Telephone: (301) 496-8528
Fax: (301) 402-5319
E-mail: [email protected]