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
- 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
- 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
- bleeding diathesis
- prior hysterectomy
- concurrent anticoagulants