National Cancer Institute, Research Contracts Branch, PSCS, 6120 Executive Blvd, EPS/RM 634 Bethesda, MD 20892-7228

B -- SPUTUM AND LUNG TUMOR MARKERS SOL NO2-CN-66214-81 POC Janet Mattson, Contracting Officer, 301-402-4509. The National Institutes of Health plans to procure on a Sole Source Basis, under authority of FAR 6.302-1, in accordance with 41 U.S.C. 253 (c)(1), sputum/lung tumor immunostaining and microsatellite marker testing from the Johns Hopkins University, School of Hygiene and Public Health, Baltimore, Maryland, 21205. This is an ongoing study and a continuation and study of additional patients and additional tests. A capability to provide qualitative/quantitative immunostaining using an established discriminant function algorithm and selected microsatellite marker analyses in lung tumor, adjacent morphologically normal tissue, and sputum specimens to identify potential markers for early detection of lung cancer is needed. The laboratory tests to be applied to the tumor and sputum specimens here (i.e., Mabs 703D4 and 624H12) and the quantification of these tests (i.e., dual wavelength image cytometry using established discriminant function algorithm) have been developed and validated in only one laboratory in the world (the laboratory of Dr. Melvyn Tockman at the Johns Hopkins University), and are only available from that laboratory. There is no place else in the world that has the expertise for the application and interpretation of these tests to satisfy the requirements of this procurement in a timely manner except the laboratory of Dr. Melvyn Tockman at the Johns Hopkins University. Further, we have already performed the immunostaining tested described here in sputum samples from 57 lung cancer cases in Dr. Tockman's laboratory and it is essential for the scientific integrity of our current effort that the additional testing be conducted in a comparable manner. Requirements include: (1) Using 130 archived historical lung cancer resection specimens from YTC miners: (1a) immunostain tumor and adjacent morphologically normal tissue with monoclonal antibodies to hnRNP and difucosylated Lewis X antigens (Mabs 703D4 and 624H12), and quantify with dual wavelength image cytometry using an established discriminant function algorithm to characterize neoplastic from adjacent morphologically normal tissue, (1b) microdissect tumor and morphologically normal tissue, and isolate DNA from each, (1c) take the isolated DNA and use microsatellite markers to probe for allelic loss and/or alteration on chromosome 3p (at THRB, D3s1284), chromosome 9p (at D9s156, D9s199, D9s200, 9p21), and chromosome 17p (CHRNB1, D17s122, and Tp53), (3) using specimens from 70 cases having microbiopsy tumor specimens and 140 paired prospective sputum specimens: (2a) immunostain paired tumor and sputum with monoclonal antibodies to hnRNP and difucosylated Lewis X antigens (Mabs 703D4 and 624H12), and quantify with dual wavelength image cytometry using an established discriminant function algorithm to characterize neoplastic from adjacent morphologically normal tissue, (2b) microdissect tumor and morphologically normal tissue and isolate DNA, microdissect and isolate DNA from exfoliated sputum epithelial cells, (2c) take the isolated DNA and use microsatellite markers to probe for allelic loss and/or alteration on chromosome 3p (at THRB, D3s1284), chromosome 9p (at D9s156, D9s199, D9s200, 9p21), and chromosome 17p (CHRNB1, D17s122, and Tp53). This notice of intent is not a request for competitive proposals, however, interested parties may identify their interest and capability to respond to the requirement. Information furnished shall include enough material, in sufficient detail, to perform a proper evaluation of their ability to perform. Closing date is 45 days after publication of this notice. (0166)

Loren Data Corp. http://www.ld.com (SYN# 0012 19960617\B-0001.SOL)