This Phase II proposal is designed to provide and analyze a database which will largely delineate whether it is worthwhile to pursue 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 the study population of 5000 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 which 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 productive 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 well characterized serum bank available for evaluation of such assays.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44CA040945-02A1
Application #
3506468
Study Section
Epidemiology and Disease Control Subcommittee 3 (EDC)
Project Start
1987-09-30
Project End
1989-09-29
Budget Start
1987-09-30
Budget End
1988-09-29
Support Year
2
Fiscal Year
1987
Total Cost
Indirect Cost
Name
Centocor, Inc.
Department
Type
DUNS #
City
Malvern
State
PA
Country
United States
Zip Code
19355
Einhorn, N; Sjovall, K; Knapp, R C et al. (1992) Prospective evaluation of serum CA 125 levels for early detection of ovarian cancer. Obstet Gynecol 80:14-8
Bast Jr, R C; Knauf, S; Epenetos, A et al. (1991) Coordinate elevation of serum markers in ovarian cancer but not in benign disease. Cancer 68:1758-63
Zurawski Jr, V R; Sjovall, K; Schoenfeld, D A et al. (1990) Prospective evaluation of serum CA 125 levels in a normal population, phase I: the specificities of single and serial determinations in testing for ovarian cancer. Gynecol Oncol 36:299-305
Zurawski Jr, V R; Orjaseter, H; Andersen, A et al. (1988) Elevated serum CA 125 levels prior to diagnosis of ovarian neoplasia: relevance for early detection of ovarian cancer. Int J Cancer 42:677-80