EXPLORATORY STUDIES IN CANCER DIAGNOSTICS

Release Date:  January 16, 1998

PA NUMBER:  PA-98-022

P.T.

National Cancer Institute

PURPOSE

The Diagnostics Research Branch of the Cancer Diagnosis Program in
the Division of Cancer Treatment and Diagnosis (DCTD) of the
National Cancer Institute (NCI) invites research grant applications
from interested investigators to conduct innovative studies in
cancer diagnostics.  Advances in understanding of basic cancer
biology and the development of powerful molecular technologies are
leading to the identification of many new abnormalities in cancer
cells.  These novel tumor characteristics can provide information
to enhance that obtained from the histopathologic features
traditionally used to diagnose cancers.

The objective of this Program Announcement is to encourage
applications from individuals who are interested in testing novel
ideas that are scientifically sound and may advance progress in
cancer diagnosis.  The  R21 grant mechanism is utilized for pilot
projects or feasibility studies to support exploratory research
that may produce innovative advances in science.  This grant
program provides limited funds (maximum of $75,000 direct costs per
year not including indirect costs of any collaborating
institutions) for short-term (up to two years) research projects.

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 PA, Exploratory Studies in Cancer Diagnostics, 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 foreign and domestic, 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 of this program will be through the National Institutes of
Health (NIH) exploratory/developmental grant (R21) mechanism.
Applicants will be responsible for the planning, direction and
execution of the proposed project.  All PHS and NIH grants policies
will apply to the applications received and awards made in response
to this program announcement.  Applicants may request up to $75,000
per year in direct costs.  (Indirect costs for collaborating
institutions, if any, will not be counted against this limit.)  The
total project period for an application submitted in response to
this PA may not exceed two years.  These grants are non-renewable,
and continuation of projects developed under this program will be
through the traditional unsolicited investigator-initiated research
grant program.

RESEARCH OBJECTIVES

Background

The Cancer Diagnosis Program supports the development of better
tools to aid in the clinical management of cancer patients.
Although clinical need drives this process, much of the early
research remains descriptive, focusing on the search for apparent
differences between tumor and normal cells.  When differences are
found, an attempt must be made to correlate the changes with
clinical parameters.  The further development and evaluation of the
approach will depend on whether it will answer a clinical question.

It has been difficult for investigators to obtain support for early
translational studies through the traditional research project
grant (R01) mechanism.  Such studies may not be sufficiently
developed for a standard R01 and may be considered high-risk. The
exploratory grant (R21) mechanism is more appropriate for these
investigations.  We expect that these R21 grants will serve as a
basis for planning future clinical research project (R01) grant
applications or NCI cooperative clinical trial group studies.

Because the exploratory grant mechanism is designed to support
innovative ideas, extensive preliminary data as evidence of
feasibility are not required.  However, the applicant must develop
a sound research plan.  The opportunity for discovery of new
information about the behavior of tumor cells and the potential
significance of the information to be obtained are major
considerations in the evaluation.

Research Goals and Scope

The major goal of this initiative is to promote the discovery of
new molecular or cellular abnormalities in tumors that will be
useful for cancer diagnosis.  Investigators are encouraged to
consider the broadest range of biological alterations in tumor
cells and tissues, not simply conventional genetic or immunologic
markers, and to explore the application of emerging new
technologies.  The emphasis in these applications should be on
discovery, rather than incremental improvements in existing
strategies.

This initiative envisions funding translational studies which
identify promising new means for cancer diagnosis and which provide
the initial, critical information necessary to decide whether
potential clinical utility justifies further investment.

This PA differs from the existing Program Announcement #PA-96-040
(Exploratory Grants for Correlative Laboratory Studies and Clinical
Trials), which solicits applications for clinical trials of new
cancer therapies and for correlative laboratory studies.  PA-96-040
invites applications leading toward more effective cancer
treatments or toward the identification of patient subsets for
specific therapeutic strategies.  This Program Announcement seeks
to encourage projects at an even earlier stage of conceptual
development.  However, proposals must be based on a strong
scientific rationale.  Laboratory research should be clearly
integrated with clinical goals, and should make use of human
materials.  Proposed projects should be designed to improve cancer
diagnosis by translating basic research findings into new ways to
examine human tissues.  Where applicable, evidence of statistical
support should be included to ensure proper correlation of
laboratory measurements with clinical outcomes.

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 policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43).

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 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. 9/95) 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 Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/710-0267, Email: ASKNIH@od.nih.gov. The title and number of the
program announcement must be typed in Section 2 on the face page of
the application.

The completed original application and five legible copies must be
sent or delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public
Health Service referral guidelines. Applications will be reviewed
for scientific and technical merit by study sections of the Center
for Scientific Review, NIH in accordance with the standard NIH peer
review procedures.  Following scientific-technical review, the
applications will receive a second-level review by the appropriate
national advisory council.

Review Criteria

The goals of NIH-supported research are to advance our
understanding of biological systems, improve the control of
disease, and enhance health.  The reviewers will comment on the
following aspects of the application in their written critiques in
order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in
assigning the overall score weighting them as appropriate for each
application.  Note that the application does not need to be strong
in all categories to be judged likely to have a major scientific
impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

1.  Significance.  Does this study address an important problem? If
the aims of the application are achieved, how will scientific
knowledge be advanced?  What will be the effect of these studies on
the concepts or methods that drive this field?  In this case, what
is the potential for translation of basic research to clinical
applications?

2.  Approach.  Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to
the aims of the project?  This includes, where applicable, the
statistical rationale for the study design and the choice of sample
size.  Does the applicant acknowledge potential problem areas and
consider alternative tactics?

3.  Innovation.  Does the project employ novel concepts, approaches
or method?  Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?

4.  Investigator.  Is the investigator appropriately trained and
well suited to carry out this work?  Is the work proposed
appropriate to the experience level of the principal investigator
and other researchers (if any)?

5.  Environment.  Does the scientific environment in which the work
will be done contribute to the probability of success?  Do the
proposed experiments take advantage of unique features of the
scientific environment or employ useful collaborative arrangements?
Is there evidence of institutional support?

The initial review group will also examine: the appropriateness of
proposed project budget and duration; the adequacy of plans to
include both genders and minorities and their subgroups as
appropriate for the scientific goals of the research and plans for
the recruitment and retention of subjects; the provisions for the
protection of human and animal subjects; and the safety of the
research environment.

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:  Quality of the proposed
project as determined by peer review, availability of funds, and
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:

Dr. Tracy G. Lugo
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, Room 700, MSC 7388
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-1591
FAX:  (301) 402-7819
Email:  TL82S@NIH.GOV

Direct inquiries regarding fiscal matters to:

Joan Metcalfe
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-7800, extension 228
FAX:  (301) 496-8601
Email:  JM158R@NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.394.  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 and contract recipients to
provide a smoke-free workplace and promote the non-use of all
tobacco products.  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.  This is
consistent with the PHS mission to protect and advance the physical
and mental health of the American people.

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