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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00039312

Enrollment

Registered

2003-01-27

Start date

1999-12-31

Completion date

2010-04-30

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

cervical cancer

Brief 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.

Interventions

OTHERPapanicolaou test

OTHERcytology specimen collection procedure

PROCEDUREannual screening

PROCEDUREcolposcopic biopsy

PROCEDUREcomparison of screening methods

Study design

Primary purpose

SCREENING

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026