NCT00039312

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
OTHER	Papanicolaou test
OTHER	cytology specimen collection procedure
PROCEDURE	annual screening
PROCEDURE	colposcopic biopsy
PROCEDURE	comparison of screening methods

Timeline

• Start date: 1999-12-01
• Primary completion: 2003-08-01
• Completion: 2010-04-01
• First posted: 2003-01-27
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States