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Comparison of Screening Tests in Detecting Cervical Neoplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00039312
First Posted: January 27, 2003
Last Update Posted: July 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  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.


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

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Multi-Institutional Prospective Cohort Study For The Comparison Of Different Primary Screening Strategies For The Detection Of Cervical Neoplasia

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 15
Study Start Date: December 1999
Study Completion Date: April 2010
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

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
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
  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


Locations
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)
Investigators
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 )
UCLA-9910034
NCI-G02-2076
First Submitted: June 6, 2002
First Posted: January 27, 2003
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
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female