Full Text PA-95-031 EARLY DETECTION RESEARCH ON CARCINOMA OF THE PANCREAS NIH GUIDE, Volume 24, Number 5, February 10, 1995 PA NUMBER: PA-95-031 P.T. 34 Keywords: Cancer/Carcinogenesis Digestive Diseases & Disorders Diagnosis, Medical Risk Factors/Analysis Disease Model National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Cancer Institute (NCI) and the Division of Digestive Diseases and Nutrition of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) wish to encourage research in strategies for the early detection and diagnosis of pancreatic cancer and the identification of individuals at high risk, such as individuals with chronic pancreatitis, who develop pancreatic neoplastic lesions. These research strategies can be devised based upon leads provided by (1) known risk factors identified through epidemiologic or cohort studies, (2) knowledge and research on pancreatitic metabolism or oncogene expression, or (3) the genetics of pancreatic metabolism, especially the activation of putative metabolic procarcinogens or cancer causing metabolites in certain populations. This program announcement is primarily designated for research on human subjects, although animal models may be used to confirm or develop specific hypotheses. 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, Early Detection Research on Carcinoma of the Pancreas, is related to the priority area of cancer prevention and control. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Eligible applicants include established or new investigators who have an interest in pancreatic cancer or the application of new laboratory technologies to the prevention or early detection of pancreatic cancer. Applicants are encouraged to develop multidisciplinary collaborations and must have access either directly or through a collaborator to patients with pancreatic cancer. Although this program announcement emphasizes studies in humans, it does not preclude studies in laboratory animals to confirm or develop new hypotheses. Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this research will be through the NIH research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. RESEARCH OBJECTIVES This program announcement calls for applied research on the detection of pancreatic cancer at an early stage or the identification of individuals who may be at high risk. In the latter case, cohort studies of patients with chronic pancreatitis or other chronic conditions associated with an increased risk of pancreatic cancer, could be conducted to identify individuals with potentially curable pancreatic cancer, markers or precursor lesions in this high risk patient population or for oncogene expression in the development of pancreatic neoplastic lesions. Early detection of established cancer can be based on blood tests or metabolic products excreted in the bile, pancreatic juice, stool or urine. Tumor associated antigens, peptide hormones and mutated oncogenes are areas of interest. Factors directly causing an increased risk of pancreatic cancer could be identified through (1) putative carcinogenic products secreted in the pancreatic juice after absorption from the intestine; (2) the ability of the pancreas to activate drugs or other chemicals to carcinogenic or toxic agents that can be detected in the blood, stool, or urine; and (3) genetic testing for the existence of specific metabolic pathways that may predispose to carcinoma. Results of the research should lead to alternate methods for early detection of pancreatic cancer; improved understanding of pancreatic metabolism, including the synthesis and secretion of specific metabolites, the possible role of the pancreas in activating (or deactivating) procarcinogens absorbed from the intestine, and whether or not metabolic pathways that may activate procarcinogens are genetically determined and vary in different populations; and the elucidation of the development of preneoplastic lesions of the pancreas to neoplasia. Early detection can include research on possible new tumor markers such as peptide hormones or glycoproteins. Patient based studies should also provide a better understanding of cancer risk and progression among groups or populations at increased risk, such as middle-age and older African American men, smokers, or patients with pancreatitis, as well as determine why the incidence and mortality of pancreatic cancer is higher in African Americans than in non-Hispanic whites. Identification of metabolic pathways associated with cancer may have advantages for cancer control since individuals who are at high risk because of pancreatic metabolism may be candidates for dietary modification or prophylatic chemotherapy. 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 4928 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 28, 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines 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 Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of the program announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892 Bethesda, MD 20817 (express mail) Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH Center for Research Resources (NCRR) may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or the principal investigator should be included with the application. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council/board. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology 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 including patient population necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or that provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with all other approved applications. 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 Program priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Donald Earl Henson, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 305 Bethesda, MD 20892 Telephone: (301) 496-9424 Email: deh@helix.nih.gov Thomas F. Kresina, PhD Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-12A MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8871 FAX: (301) 480-8300 Email: tfk@cu.nih.gov Direct inquiries regarding fiscal and administrative matters to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ex 213 Mrs. Thelma Jones Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20982-6600 Telephone: (301) 594-8853 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399 and No. 93.848. 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. 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. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |