Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00039312


Primary Contact:

Study Chair
Christine Holschneider, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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