NCT00237562

Brief Summary

  1. 1.Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;
  2. 2.Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;
  3. 3.Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);
  4. 4.Determine satisfaction and compare it between women assigned to the SVP and the UCP;
  5. 5.Determine the cost-effectiveness and compare it between the SVP and UCP

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

May 5, 2006

Status Verified

October 1, 2005

First QC Date

October 10, 2005

Last Update Submit

May 4, 2006

Conditions

Cervical Intraepithelial Neoplasia

Interventions

Large loop electrosurgical excisionPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years
  • No history of invasive cervical cancer
  • Not pregnant

You may not qualify if:

  • Absence of a cervix
  • Abnormal vaginal bleeding
  • Cervical cancer screening within the previous 12 months
  • A known bleeding disorder
  • Reluctance to be randomized
  • Unwillingness to follow the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

Related Publications (1)

  • Brewster WR, Hubbell FA, Largent J, Ziogas A, Lin F, Howe S, Ganiats TG, Anton-Culver H, Manetta A. Feasibility of management of high-grade cervical lesions in a single visit: a randomized controlled trial. JAMA. 2005 Nov 2;294(17):2182-7. doi: 10.1001/jama.294.17.2182.

    PMID: 16264159RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Alberto Manetta, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

July 1, 1999

Last Updated

May 5, 2006

Record last verified: 2005-10

Locations

US(1)