SOLICITATION NOTICE
A -- Preclinical Evaluation of Intermediate Endpoints and the Modulation by Chemopreventive Agents, WS, 71-78
- Notice Date
- 7/19/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFP-N01-CN-35006-72
- Response Due
- 10/15/2002
- Point of Contact
- Jacqueline Ballard, Contracting Officer, Phone (301) 435-3795, Fax (301) 402-8579,
- E-Mail Address
-
jb335w@nih.gov
- Description
- DESC: The National Cancer Institute, Division of Cancer Prevention, (DCP) Chemoprevention Agent Development Research Group (CADRG) is interested in conducting animal cancer model studies of biomarkers and intermediate endpoints that might be used in human clinical trials in order to examine in detail the biomarker modulating effects of selected chemopreventive compounds. In addition the studies will improve biomarker sensitivity, specificity, assay methodology, and sample handling. The emphasis will be on efficient studies aimed at providing more quantitative, and more validated intermediate endpoints for future human clinical trials. Intermediate endpoints or biomarkers that are directly associated with the evolution of neoplasia, and that develop with much higher frequency in abnormal cells of susceptible individuals than do the actual tumors, will make it possible in the future to carry out many studies on fewer subjects for shorter durations. If such biomarkers were found to be modified by a particular intervention regimen in preclinical studies, a rationale would be provided for carrying out clinical studies. The application of biological markers to clinical cancer prevention trials carries great promise in relation to ultimate cancer prevention. When neoplasia itself is used as an end point in studies of this type, a very large number of subjects tested for long durations are often required. The results of these in vivo experiments will be used to select promising intermediate endpoints for Phase II human studies whose objectives are to study the modulation of a selected biomarker in response to a chemopreventive agent. These relevant preclinical studies will be used to help achieve one of the major goals of the chemoprevention program which is the timely evaluation of chemopreventive agents in clinical trials. A number of chemical compounds and/or dietary components have been shown to inhibit carcinogenesis in animal models, in vitro systems, and to be associated with cancer reduction in epidemiological studies. Results from animal studies suggest that a number of compounds and/or dietary components may affect several stages of carcinogenesis. A variety of excellent biomarkers are now available. Examples include reversal of abnormal cytology, ornithine decarboxylase activity, prostaglandin synthetase inhibition, DNA ploidy alterations, changes in cellular proliferation (e.g., tritiated thymidine or BrdU labeling indices, decreases in PCNA or Ki-67 antigens, or histology), and oncogene suppression tests. The development and utilization of sensitive and accurate intermediate endpoints should enhance the ability to design effective human Phase II clinical trials. This RFP will involve eight (8) workstatements (Nos. 71-78). Certain study design characteristics apply to the specific Workstatements under this RFP. Most of the requirements for the Workstatement study design will be detailed in the specific workstatement. Each workstatement will have a specific period of performance. The workstatements are: Workstatement #71-Use Of Survivin In Preclinical Studies: Characterization Of Survivin In Various Animal Models And Development Of A Transgenic Mouse Model Overexpressing Survivin; Workstatement # 72- Intermediate Surrogate Biomarker Studies in Squamous Cell Carcinoma of the Respiratory Tract Using Optical Photospectroscopy Analysis; Workstatement #73-Use Of FHIT In Preclinical Studies: Characterization Of FHIT Expression In Various Animal Models And Determination Whether Methylation Of The FHIT Gene Is The Cause Of Altered Expression; Workstatement #74-Effects of Treatment with Putative Chemopreventive Agents on Intermediate Endpoints of Disease Progression in a Transgenic Animal Model of Intestinal Cancer: Study of Tcf4 Activation in ApcMin Mice; Workstatement #75- Effects of Chemopreventive Agents on Tobacco Smoke-induced Mutagenesis in the lacZ Transgenic Mouse; Workstatement #76-Preclinical Evaluation of Intermediate Endpoints and Their Modulation by Tobacco Smoke in a Transgenic Mouse Model of Esophageal Cancer; Workstatement #77- Evaluation of Ovarian Cancer Chemopreventive Agents in Chickens; Workstatement #78- Effects of topically applied chemopreventive agents and diet in SKH-1 mice: A chemoprevention model for basal cell carcinoma. It is anticipated that this RFP will be available electronically on or before August 15, 2002 to all Master Agreement Holders (MAH). In order to be considered for award, all offerors shall be a Holder and a member of the Preclinical Evaluation of Intermediate Endpoints and the Modulation by Chemopreventive Agents pool as of the release date of this RFP. All questions should be directed, via facsimile or e-mail to Jacqueline Ballard, Contracting Officer, Prevention and Control Population Sciences Contracts Section, Research Contracts Branch, National Cancer Institute, NIH, Executive Plaza South, Room 6000, 6120 Executive Boulevard, MSC 7195 Rockville, Md. 20852. Phone: 301-435-3795; Fax: 301-402-8579; Email address: ballardj@mail.nih.gov . The North American Industry Classification System (NAICS) code is 541710. All request should reference the RFP No. N01-CN-35006-72. No collect calls will be accepted. Number Note 26 - Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify their interest and capability to the contracting officer to satisfy the Government's requirement with a commercial item within 15 days of this notice.
- Record
- SN00121146-W 20020721/020719213231 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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