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.
Other: Papanicolaou test
Other: cytology specimen collection procedure
Procedure: annual screening
Procedure: colposcopic biopsy
Procedure: comparison of screening methods
|Study Design:||Primary Purpose: Screening|
|Official Title:||Multi-Institutional Prospective Cohort Study For The Comparison Of Different Primary Screening Strategies For The Detection Of Cervical Neoplasia|
|Study Start Date:||December 1999|
|Study Completion Date:||April 2010|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039312
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Christine Holschneider, MD||Jonsson Comprehensive Cancer Center|