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Comparison of Screening Tests in Detecting Cervical Neoplasia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00039312
First received: June 6, 2002
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00039312     History of Changes
Other Study ID Numbers: 99-10-034, P30CA016042, UCLA-9910034, NCI-G02-2076
Study First Received: June 6, 2002
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Jonsson Comprehensive Cancer Center:
cervical cancer

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

ClinicalTrials.gov processed this record on June 18, 2013