Notice of Availability of Blood Samples for Validations of Lung Cancer Biomarkers

Notice Number: NOT-CA-07-016

Key Dates
Release Date: May 14, 2007

Issued by
National Cancer Institute (NCI), (http://www.nci.nih.gov/)

Purpose

Early detection of lung cancer is urgently needed in the management of this deadly disease. Despite recent advances in molecular diagnostics, no specific biomarker for the early detection of lung cancer has reached the clinic. New non-invasive discovery approaches for the early diagnosis of lung cancer have led to the identification of a series of blood-based candidate cancer biomarkers using genomic, epigenomic, and proteomic methods. These approaches may provide the tools necessary to achieve these goals, but they are impacted by issues of reproducibility within analyses as well as across discovery and analytical platforms. These important issues can be addressed efficiently with independent validations of biomarkers in numerically large sets of well-annotated samples from multiple institutions that allow rigorous comparisons of discovery data for the purposes of determining diagnostic accuracies.

To meet this need, the Lung Cancer Biomarkers Group (LCBG) developed a requisite sample resource to validate blood based biomarkers for the early diagnosis of lung cancer. The LCBG is made up of scientists from the Early Detection Research Network (EDRN), the Lung Cancer Specialized Programs of Research Excellence (Lung Cancer SPOREs), the intramural program at the NCI Center for Cancer Research, and several other lung cancer research programs. The specific goals of the NCI-led LCBG include: to develop reference case/control serum/plasma sets held in an NCI repository; to make these samples available to interested members of the research community; to refine and validate blood-based biomarkers for lung cancer; to test the reproducibility of biomarkers within and across institutions; and to test the reproducibility of biomarkers within and across analytical platforms.

At present, four reference sets have been planned using serum and plasma samples. The first two reference sets (A and B) are being deposited in the NCI repository in Frederick, MD. These samples represent the collection of retrospectively collected and clinically annotated blood samples from eight institutions around the United States. Prospective collections from six institutions are on-going under a unique standard operating procedure of two additional reference sets (C and D). Sets A and C (180 lung cancer cases > 50% Stage I, 180 matched controls, over 50 samples from patients with other types of cancer) will provide an opportunity to pre-validate biomarkers for the diagnosis of lung cancer from patients with an abnormal chest X-ray or at high risk for lung cancer. Sets B and D (170 lung cancer cases, 250 matched controls) will provide an opportunity to prevalidate biomarkers for early detection of lung cancer in the context of computed-tomography (CT) screening of high risk individuals. Patients presenting with suspicious nodules between 0.5 – 3 cm on computed tomography (CT)-screening are required for inclusion in sets B and D. All sets are subdivided into smaller subsets for rapid pre-validation of individual biomarkers, whereas the full sets are required for pre-validation of multi biomarker panels or for full validation. These reference sets will be assembled and stored at the NCI facility in Frederick, MD.

Any investigator studying promising lung cancer biomarkers can request access to the above-mentioned sets of specimens. Set A will become available this summer and Set B should be available later in the year. Your request(s) will be considered and approved or disapproved by an internal review committee established by the LCBG. The detailed protocol for requesting access to these samples will be available on the EDRN website (http://edrn.nci.nih.gov/resources/sample-reference-sets).

Inquiries

Karl Krueger, Ph.D.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3137, MSC 7362
Bethesda, MD 20892-7362 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 435-1594
Fax: (301) 402-8990
E-mail: kruegerk@mail.nih.gov

Peter Ujhazy M.D., Ph.D.
Organ Systems Branch
Office of Centers, Training, and Resources
Office of the Director National Cancer Institute
6116 Executive Boulevard, Suite 7013, MSC 8347
Bethesda, MD 20892-8347 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8528
Fax: (301) 402-5319
E-mail: ujhazyp@mail.nih.gov


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