NCT00039312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

3.7 years

First QC Date

June 6, 2002

Last Update Submit

July 30, 2020

Conditions

Cervical Cancer

Keywords

cervical cancer

Interventions

Papanicolaou testOTHER
cytology specimen collection procedureOTHER
annual screeningPROCEDURE
colposcopic biopsyPROCEDURE
comparison of screening methodsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • bleeding diathesis
  • pregnant
  • prior hysterectomy
  • concurrent anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christine Holschneider, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

December 1, 1999

Primary Completion

August 1, 2003

Study Completion

April 1, 2010

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)