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CompletedNCT00039312Updated Aug 3, 2020

Comparison of Screening Tests in Detecting Cervical Neoplasia

An interventional study of Papanicolaou test and cytology specimen collection procedure in Cervical Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-03.

Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
15
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Cancer

Keywords

  • cervical cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Enrollment
15 participants (actual)

Interventions

  • OtherPapanicolaou test
  • Othercytology specimen collection procedure
  • Procedureannual screening
  • Procedurecolposcopic biopsy
  • Procedurecomparison of screening methods
06

Study locations

1 site
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00039312
Lead sponsor
Jonsson Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Dec 1999
Primary completion
Aug 2003
Completion
Apr 2010
Last update
Aug 3, 2020

Study contacts

Christine Holschneider, MD
study chair · Jonsson Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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