The proposed project is a continuation of our ongoing stratified, randomized, double-blind phase III chemoprevention of cervical dysplasia trial initiated in 1985 (CA 40889). The objective of this project is to complete evaluation of a group of 300 women with moderate or severe cervical dysplasia who have received either beta-trans retinoic acid or placebo cream applied directly to the cervix.
Specific aims of the project are to: 1) increase the regression frequency for moderate and severe dysplasia, and 2) reduce the frequency of progression of moderate dysplasia to severe dysplasia or carcinoma in situ. Additionally, compliance and local and systemic toxicities are documented. Subject accrual is 100%, and continuation is needed for subject follow-up and final data analysis. We have answered the reviewers' critique, and amended the application and revised the budget according to their comments. In addition, indirect costs will be calculated at the lower, off- campus rate. The completion of this study will provide useful new information regarding the chemopreventive effects of retinoids on cervical dysplasia.
| Meyskens Jr, F L; Surwit, E; Moon, T E et al. (1994) Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial. J Natl Cancer Inst 86:539-43 |
| Loescher, L J; Graham, V E; Aickin, M et al. (1990) Development of a contingency recruitment plan for a phase III chemoprevention trial of cervical dysplasia. Prog Clin Biol Res 339:151-63 |
| Aickin, M (1990) Maximum likelihood estimation of agreement in the constant predictive probability model, and its relation to Cohen's kappa. Biometrics 46:293-302 |
| Graham, V; Surwit, E S; Weiner, S et al. (1986) Phase II trial of beta-all-trans-retinoic acid for cervical intraepithelial neoplasia delivered via a collagen sponge and cervical cap. West J Med 145:192-5 |
