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

301/435-0714; 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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