Clinical Trial: Comparison of Screening Tests in Detecting Cervical Neoplasia

This study is no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention
Cervical Cancer
 Procedure: annual screening
 Procedure: colposcopic biopsy
 Procedure: comparison of screening methods
 Procedure: cytologic sampling
 Procedure: diagnostic test
 Procedure: screening intervention
 Procedure: vaginal smears

MedlinePlus related topics:  Cervical Cancer

Study Type: Observational
Study Design: Screening

Official Title: Study of Primary Screening Strategies For the Detection of Cervical Neoplasia

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS: Age:

  • Over 18

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • No bleeding diathesis

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

Other:

  • No concurrent anticoagulants

Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Christine Holschneider, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069371; UCLA-9910034; NCI-G02-2076
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2002
ClinicalTrials.gov Identifier:  NCT00039312
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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