SBIR-STTR Award

Phase I will investigate the feasibility of conducting larger studies to determine whether the CA 125 immunoradiometric assay (IRMA), which measures tumor-associated antigenic determinants in serum, will be useful for early detection of ovarian cancer among asymptomatic women. The aims of the present investigation will be 1. to formulate a final protocol for a larger study; 2. to develop methods to standardize: data, evaluation of data and subjects, followup and study end points; 3. to make provisions for human subject committee requirements, subject registration and followup, collection and forwarding of samples and data, checking data for compliance, maintaining security of data, keeping investigators informed of study changes, developments and outcomes and analyzing data and reporting final results; 4. to identify an appropriate study population; 5. to assemble a group of investigators willing to enter subjects and follow the protocol; 6. to gather preliminary performance data on the CA 125 IRMA to justify proceeding with a larger study.The principal end points of the Phase I study will include final protocols, companion forms, a clear plan to proceed to the next Phase and publications resulting from performance data collection. These results should also provide a model for future evaluation of serum assays for such purposes.National Cancer Institute (NCI)

This Phase II proposal is designed to provide and analyze a database that will largely delineate the feasibility of pursuing a Phase III study of the CA 125 immunoradiometric assay (IRMA) as a component of strategy aimed at early detection and diagnosis of ovarian cancer in an at-risk population. Specific objectives will include: (1) accurate determination of the specificity of the test for ovarian cancer used one time and serially in a study population of 5,000 women aged 40 years or older, (2) determination of the nature of apparent false-positive results of this test, (3) identification of possible confirmatory tests that will improve the specificity of the CA 125 IRMA for ovarian cancer, and (4) preliminary retrospective estimates of the sensitivity of the CA 125 IRMA for occult ovarian cancer.The principal endpoints of this study will be: (1) a plan to proceed to a prospective study of 50,000 or more women to determine accurately the sensitivity and positive predictive value of the CA 125 IRMA and associated confirmatory and adjunctive tests for the early detection of ovarian carcinoma in an at-risk population, and (2) a collection of data allowing for determination of the cost effectiveness of such a screening strategy. The results of this study should also provide a model for future evaluation of serum assays for such purposes and establish a wellcharacterized serum bank for evaluation of such assays.National Cancer Institute (NCI)