THE ROLE OF HELICOBACTER IN CANCER NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA AVAILABLE: CA/DK-94-024 P.T. 34 Keywords: Cancer/Carcinogenesis Etiology Microbiology National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 17, 1994 Application Receipt Date: August 11, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated research grant applications to support basic studies on defining the role of the bacteria Helicobacter in human cancer. 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 RFA, The Role of Helicobacter in Cancer, 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 "Healthy People 2000" (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 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. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for each application submitted in response to this RFA may not exceed four years. The anticipated Award date is April 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $2,000,000 ($1,500,000 from NCI and $500,000 from NIDDK) in total costs per year for up to four years will be committed to fund applications which are submitted in response to this RFA. It is anticipated that eight to nine awards will be made. RESEARCH OBJECTIVES Epidemiologic studies have consistently demonstrated an association between Helicobacter pylori and gastric cancer. A recent study of over 3000 subjects from 13 countries showed a six-fold risk of gastric cancer in populations with H. pylori infection compared to populations with no infections. A longitudinal study of patients with gastric adenocarcinoma showed that H. pylori infection was a risk factor, and while the relationship between H. pylori and gastric lymphoma of mucosa-associated lymphoid tissue (MALT) was only suggestive at that time, H. pylori has subsequently been confirmed as a risk factor for gastric lymphoma. These population studies indicate that H. pylori infections acquired in childhood lead to chronic gastritis that persists for decades, and in susceptible people progresses to atrophic gastritis, intestinal metaplasia and dysplasia. In underdeveloped countries, up to 50 percent of children are infected by the age of 10 years, and while the childhood prevalence is lower for most populations, up to 50 percent of adults are infected by age 60. While there are socioeconomic, dietary and other cofactors involved in gastric cancer, the lack of a basic understanding of the oncogenic mechanism of H. pylori and its role as a factor or co-factor in gastric cancer limits our understanding of this disease. On October 16, 1993, the Biological Carcinogenesis Branch, DCE, NCI sponsored a workshop entitled "Helicobacter and Cancer." Dr. Webster Cavenee, a member of the DCE Board of Scientific Counselors, chaired the workshop. The purpose of the workshop was to assess the current state of knowledge on the role of Helicobacter pylori in gastric cancer in humans. This RFA is issues in accordance with the workshop recommendations that extramural research be stimulated in this area with set-aside funds. SPECIAL REQUIREMENTS The principal investigator of an R01 application must spend a minimum of 20 percent time and effort on this project. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by June 17, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA 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 subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. It also allows Institute staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Thomas E. Nightingale at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; 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; and from the NCI Program Director listed under INQUIRIES. Applications must be received by August 11, 1994. An application received after that date will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institutes in accordance with the review criteria listed below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the appropriate ICD's National Advisory Council/Board. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The following review criteria will apply: 1. The scientific merit, technical and medical significance of the proposed research, including the appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 2. The research experience, expertise and qualifications of the principal investigator and proposed staff and/or collaborators to perform the proposed experiments. 3. Documentation of the adequacy of the facilities and resources necessary to perform the research. AWARD CRITERIA The earliest anticipated date of award is April 1, 1995. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding fiscal matters, and address the letter of intent to: Thomas E. Nightingale, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-1951 Frank A. Hamilton, M.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive Disease and Kidney Diseases Westwood Building, Room 3A15B Bethesda, MD 20892 Telephone: (301) 594-7571 Direct inquiries regarding fiscal matters to: Mr. Earl Bowman, Jr. Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 217 Mrs. Thelma Jones Grants Management Branch National Institute of Diabetes and Digestive Disease and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.393, Cancer Cause and Prevention Research. Awards are made under the authorization of the Public Health Service (PHS) Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 U.S.C. 241 and 285) and administered under PHS and HHS grants policies and grant regulations and Federal Regulations 42 CFR Part 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. .
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