Full Text PAR-97-021 HIGH-THROUGHPUT TECHNOLOGIES TO DETECT ALTERATIONS IN TUMORS NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PAR-97-021 P.T. 34 Keywords: Cancer/Carcinogenesis Diagnosis, Medical Oncology National Cancer Institute PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites Program Project grant applications (P01s) proposing the development of high-throughput technologies for the evaluation of the spectrum of molecular alterations in primary tumor tissue. To take full advantage of the advances made in sequencing of the human genome and in our understanding of the alterations underlying cancer, it will be necessary to develop new and improved technologies to scan the entire genome of a cancer cell or of tumor tissue for constellations of gene mutations and to identify changes in gene expression at the level of both RNA and protein. Assessing the potential utility of these new techniques for doing genome-wide genetic analyses or for analyzing patterns of protein expression will require the coordination of technology development efforts with the application of the technologies to appropriate clinical specimens. The P01 funding mechanism is being used to facilitate collaborations between researchers developing novel technologies and clinical investigators with the appropriate expertise and resources to assess the application of the technologies to tumor specimens. The Advanced Technology Program (ATP) of the National Institute of Standards and Technology (NIST) is supporting commercial organizations to develop DNA-based technologies for a wide variety of diagnostic applications. The current Program Announcement will complement this important effort by supporting application of these and other technologies to the analysis of tumor tissue and by supporting the modification of technologies to optimize their utility in the clinical setting. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), High-Throughput Technologies to Detect Alterations in Tumor Specimens, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit, and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications may be from single institutions but collaborative studies between companies developing technologies and institutions with clinical resources and expertise are also encouraged. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) program project grant (P01) mechanism. The applications should be constructed using the P01 application guidelines of the NCI. The P01 mechanism is designed to support multiple, interacting projects focused on a central theme. P01s may support projects that are performed at multiple sites but coordinated by a single principal investigator at the grantee institution. PIs will be responsible for the planning, direction and execution of the proposed project. Applicants may request up to $750,000 per year direct cost, however, each budget item must be carefully justified (See Letter of Intent). The period of support for applications submitted in response to this PA may be for up to five years. This PA will be in effect for two years, up to and including the October 1, 1998 P01 receipt. RESEARCH OBJECTIVES Background The impressive advances in our understanding of the molecular alterations underlying tumor initiation and progression coupled with the sequencing of the entire human genome will provide the intellectual basis for dramatic changes in the way cancer patients are managed. Previous studies to correlate alterations in tumors to clinical parameters have suggested the potential importance of measuring these changes as a part of clinical decision-making. The sequencing of the human genome and ongoing development of technologies to analyze genetic alterations on a genome-wide scale may soon make it feasible to simultaneously look at all or a subset of the alterations in tumor tissue. Similar technologies to detect patterns of protein expression or to detect changes in proteins functioning in pathways of cellular regulation are also needed. The development of these new technologies will facilitate the discovery of new alterations in tumor cells and, ultimately, the rapid collection of diagnostic and prognostic information that may be useful in cancer patient management. Research Goals and Scope This initiative invites grant applications to support development of high-throughput technologies for analysis of the spectrum of molecular alterations in primary tumor tissues. The applications should propose development of appropriate technologies and studies to assess their use in analysis of primary tumor specimens. Modification of these technologies to optimize their utility in the clinical setting may also be proposed. Technologies may be designed to analyze a variety of alterations including genome-wide cytogenetic changes; mutations in constellations of genes known to be important in tumor initiation and progression, including genes that are members of pathways of cellular regulation; analysis of all possible mutations in a single gene; changes in patterns of gene expression at the level of both RNA and protein; or changes in protein function. The applications must document access to appropriate tumor tissue resources to facilitate evaluation of the technologies in clinical specimens. Development of informatics systems to support collection and evaluation of research data may also be proposed. This program encourages interactions among academic scientists and clinicians, basic scientists involved in the development of new technologies and informatics specialists. The initiative envisions collaborations among commercial or academic organizations with appropriate programs in technology development and academic institutions with expertise and ongoing programs in cancer biology and genetics with the necessary clinical resources. These collaborations will ensure that the technologies developed are appropriate steps toward meeting the clinical needs of the cancer community. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research and a list of titles for the anticipated components of the P01, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Applicants requesting budgets greater than $500,000 are required to contact NCI program staff prior to submitting their applications (NIH GUIDE, Vol. 25, No. 14, May 3, 1996). Applications with budgets of more than $500,000 received without prior communication with the NCI program staff listed under INQUIRIES will not be accepted for review. The letter of intent is to be sent to the Referral Officer, National Cancer Institute at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 5/95) and will be accepted at the standard deadlines for P01 applications as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, e-mail: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in line 2 of the face page of the application and the YES box must be marked. The completed original application and three legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) In addition send two complete copies under separate cover to: REFERRAL OFFICER NATIONAL CANCER INSTITUTE EXECUTIVE PLAZA NORTH, ROOM 636A 6130 EXECUTIVE BOULEVARD, MSC 7405 BETHESDA, MD 20892-7405 ROCKVILLE, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Services referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by the Grants Review Branch of the Division of Extramural Activities of NCI. The second level of review will be provided by the National Cancer Advisory Board. Review criteria that will be used to assess the scientific merit of an application are: o scientific and technical merit and originality of the proposed research; o appropriateness and adequacy of the experimental approach proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NCI. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Responsiveness to the goals and objectives of the PA INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James W. Jacobson, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: JJ37D@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Teresa Mercogliano Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 243 FAX: (301) 496-8601 Email: MERCOGLT@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnostic Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. .
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