Comparison of Screening Tests in Detecting Cervical Neoplasia
|ClinicalTrials.gov Identifier: NCT00039312|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 31, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: Papanicolaou test Other: cytology specimen collection procedure Procedure: annual screening Procedure: colposcopic biopsy Procedure: comparison of screening methods||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|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|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||April 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|