This phase I SBIR proposal will investigate the feasibility of conducting larger studies to determine whether the CA 25 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 to: (1) formulate a final protocol for a larger study; (2) develop methods to standardize data, evaluation of data and subjects, followup, and study end points; (3) 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) identify an appropriate study population; (5) assemble a group of investigators willing to enter subjects and follow the protocol; and (6) 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 tne 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. (5)
|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|
|Zurawski Jr, V R; Broderick, S F; Pickens, P et al. (1987) Serum CA 125 levels in a group of nonhospitalized women: relevance for the early detection of ovarian cancer. Obstet Gynecol 69:606-11|
|Green, P J; Ballas, S K; Westkaemper, P et al. (1986) CA 19-9 and CA 125 levels in the sera of normal blood donors in relation to smoking history. J Natl Cancer Inst 77:337-41|