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