Comparison of Screening Tests in Detecting Cervical Neoplasia
Comparison of Screening Tests in Detecting 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