National Cancer Institute - NCI Division of Cancer Treatment and ...
National Cancer Institute - NCI Division of Cancer Treatment and ... National Cancer Institute - NCI Division of Cancer Treatment and ...
Correlative Studies with Specimens from Multisite Trials Program Announcements: PA-05-062: http://grants.nih.gov/grants/ guide/pa-files/PA-05-062.html (expiration date 3/2/2008) and PA-06-296: http://grants.nih. gov/grants/guide/pa-files/PA-06-296.html (expiration date 3/2/2008) Contact: Heng Xie, M.D., M.P.H. 301-496-8866, xiehe@mail.nih.gov Over the past five years, NCI has sponsored more than 1500 clinical trials, including cancer treatment and prevention trials. More than 200,000 cancer patients have participated in these trials. CDP, in collaboration with other NCI programs, is tapping into the wealth of tumor specimens and accompanying information about patients that is available through these myriad trials. The tumor specimens can be used to evaluate and possibly validate diagnostic and prognostic biomarkers. They can be used to evaluate molecules and proteins relating to cell cycle or intracellular signal transduction pathways, as well as to provide informative molecular profiles relevant to cancer intervention and progression. These extremely valuable resources offer a tremendous opportunity to identify new mechanisms and develop more effective cancer interventions at a molecular level. The next step is to conduct clinical translational research on promising predictive and prognostic tumor markers. This funding opportunity will use the R01 investigator-initiated research grant mechanism to support clinical correlative studies on large, multi-institutional clinical ■ ■ ■ CDP is homing in on clinical correlative or mechanistic studies that will be useful for cancer risk assessment, early detection, and prognosis, as well as predicting responses to therapy and prevention interventions. trials to validate promising tumor markers and the exploratory/pilot grant mechanism (R21) to support pilot exploratory studies. Because the nature and scope of the proposed research will vary, the size and duration of the awards will also vary, although funding under the R21 mechanism is limited to two years. Through these grants, CDP is encouraging researchers to take advantage of newly developed technologies and existing tumor specimens. By fostering collaborations among basic researchers, scientists working in private industry, and clinical investigators, CDP is homing in on clinical correlative or mechanistic studies that will be useful for cancer risk assessment, early detection, and prognosis, as well as predicting responses to therapy and prevention interventions. C A N C E R D I A G N O S I S P R O G R A M ■ 35
P A R T N E R S H I P S A N D C O L L A B O R A T I O N S European Organisation for Research and Treatment of Cancer http://www.eortc.be CDP has led an NCI collaboration with EORTC to convene the NCI/EORTC biannual meetings on molecular diagnostics. At the first meeting, held in Denmark in 2000, four international working groups were established. One of the working groups focused on development of guidelines for information that should be included in all publications about tumor markers. These recommendations were recently published simultaneously in several major scientific journals. U.S. Food and Drug Administration http://www.fda.gov Through an agreement with the FDA, a CDP staff member has a joint appointment with NCI and FDA. This person has primary responsibility as a program director managing a portfolio of technology development and proteomics grants in the CDP Diagnostic Biomarkers and Technology Branch. At FDA, the staff person runs a laboratory that is carrying out 36 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6 research on microarray methods (a powerful technology that allows simultaneous measurement of expression levels for up to tens of thousands of genes) for detecting food-borne pathogens. The technology used at FDA is complementary to the technologies being used to detect molecular changes in cancer at NCI. The staff person also serves as a liaison between NCI and FDA on issues related to technology applications. National Institute of Standards and Technology, FDA, and College of American Pathologists http://www.nist.gov http://www.fda.gov http://cap.org Overexpression of the Her2 gene plays a pivotal role in oncogenesis, progression, and metastasis of breast cancer tumors. Her2 testing is used to decide whether a patient with breast cancer is likely to benefit from treatment with trastuzumab after her surgery. CDP cosponsored a workshop on the need for reference material to ensure the reliability of Her2 testing.
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P A R T N E R S H I P S A N D C O L L A B O R A T I O N S<br />
European Organisation for<br />
Research <strong>and</strong> <strong>Treatment</strong> <strong>of</strong> <strong>Cancer</strong><br />
http://www.eortc.be<br />
CDP has led an <strong>NCI</strong> collaboration with<br />
EORTC to convene the <strong>NCI</strong>/EORTC biannual<br />
meetings on molecular diagnostics.<br />
At the first meeting, held in Denmark in<br />
2000, four international working groups<br />
were established. One <strong>of</strong> the working<br />
groups focused on development <strong>of</strong><br />
guidelines for information that should be<br />
included in all publications about tumor<br />
markers. These recommendations were<br />
recently published simultaneously in<br />
several major scientific journals.<br />
U.S. Food <strong>and</strong> Drug Administration<br />
http://www.fda.gov<br />
Through an agreement with the FDA, a<br />
CDP staff member has a joint appointment<br />
with <strong>NCI</strong> <strong>and</strong> FDA. This person has primary<br />
responsibility as a program director<br />
managing a portfolio <strong>of</strong> technology<br />
development <strong>and</strong> proteomics grants in<br />
the CDP Diagnostic Biomarkers <strong>and</strong> Technology<br />
Branch. At FDA, the staff person<br />
runs a laboratory that is carrying out<br />
36 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6<br />
research on microarray methods (a powerful<br />
technology that allows simultaneous<br />
measurement <strong>of</strong> expression levels for up<br />
to tens <strong>of</strong> thous<strong>and</strong>s <strong>of</strong> genes) for detecting<br />
food-borne pathogens. The technology<br />
used at FDA is complementary to<br />
the technologies being used to detect<br />
molecular changes in cancer at <strong>NCI</strong>.<br />
The staff person also serves as a liaison<br />
between <strong>NCI</strong> <strong>and</strong> FDA on issues related<br />
to technology applications.<br />
<strong>National</strong> <strong>Institute</strong> <strong>of</strong> St<strong>and</strong>ards<br />
<strong>and</strong> Technology, FDA, <strong>and</strong> College<br />
<strong>of</strong> American Pathologists<br />
http://www.nist.gov<br />
http://www.fda.gov<br />
http://cap.org<br />
Overexpression <strong>of</strong> the Her2 gene plays a<br />
pivotal role in oncogenesis, progression,<br />
<strong>and</strong> metastasis <strong>of</strong> breast cancer tumors.<br />
Her2 testing is used to decide whether a<br />
patient with breast cancer is likely to benefit<br />
from treatment with trastuzumab after<br />
her surgery. CDP cosponsored a workshop<br />
on the need for reference material to<br />
ensure the reliability <strong>of</strong> Her2 testing.