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Comparison of Screening Tests in Detecting Cervical Neoplasia

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ClinicalTrials.gov Identifier: NCT00039312
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cervical Cancer Other: Papanicolaou test Other: cytology specimen collection procedure Procedure: annual screening Procedure: colposcopic biopsy Procedure: comparison of screening methods

Detailed Description:


  • 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Primary Purpose: Screening
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
Primary Completion Date : August 2003
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Christine Holschneider, MD Jonsson Comprehensive Cancer Center
More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00039312     History of Changes
Other Study ID Numbers: 99-10-034
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female