Trial Information

Multi-Institutional Prospective Cohort Study For The Comparison Of Different Primary Screening Strategies For The Detection Of Cervical Neoplasia

OBJECTIVES:

- Compare the sensitivity and specificity of primary screening strategies for the
detection of cervical intraepithelial or invasive neoplasia.

- Compare the positive and negative predictive values of these strategies.

OUTLINE: This is a multicenter study. Patients are stratified according to the reason for
the visit (general gynecological screening vs colposcopy referral).

- Stratum 1 (general gynecological screening): Patients undergo Pap smear, visual
inspection aided by acetic acid (VIA), a colposcopy, and finally a visual inspection
aided by toluidine blue (VIT) followed by an acetic acid wash. A biopsy may be
performed at this initial visit. Within 2-3 weeks, patients are notified of results.

- Stratum 2 (colposcopy referral): Patients undergo Pap smear, VIA, colposcopy, VIT, and
possible biopsy as in stratum 1. During the same visit, patients receive histologic
evaluation and treatment with See-and-Treat loop electrosurgical excision procedure
and/or endocervical curettage.

PROJECTED ACCRUAL: A total of 600-1,000 patients (300-500 per stratum) will be accrued for
this study.