Comparison of Screening Tests in Detecting Cervical Neoplasia

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

RATIONALE: Screening tests may help doctors detect abnormal cells in the cervix early and plan effective treatment. PURPOSE: Screening trial to compare different types of screening tests used to detect 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.

Inclusion Criteria:: History of cervical neoplasia Presenting for a well-woman visit, annual Pap smear, or family planning Other gynecological or non-gynecological complaints allowed OR Referred for colposcopy secondary to an abnormal Pap smear Planned screening for cervical cancer Over 18 years of age Prior laser surgery, cryotherapy, or conization or loop electrosurgical excision procedure for cervical neoplasia allowed Exclusion Criteria: bleeding diathesis pregnant prior hysterectomy concurrent anticoagulants