Full Text PA-95-031


NIH GUIDE, Volume 24, Number 5, February 10, 1995

PA NUMBER:  PA-95-031

P.T. 34

  Digestive Diseases & Disorders 
  Diagnosis, Medical 
  Risk Factors/Analysis 
  Disease Model 

National Cancer Institute
National Institute of Diabetes and Digestive and Kidney Diseases


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.


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).


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

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.


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


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.


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.


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 301/435-0714.  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.


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

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

The initial review group will also examine the provisions for the
protection of human and animal subjects, the safety of the research

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.


Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program priority


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


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.


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