- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
Collaborators and Investigators
Investigators
- Study Chair: Christine Holschneider, MD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-10-034
- UCLA-9910034
- NCI-G02-2076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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