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Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

Primary Purpose

Cervical Intraepithelial Neoplasia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Large loop electrosurgical excision

About this trial

This is an interventional prevention trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Older than 18 years No history of invasive cervical cancer Not pregnant Exclusion Criteria: 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

Sites / Locations

University of California, Irvine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00237562

First Posted

October 10, 2005

Last Updated

May 4, 2006

Sponsor

University of California, Irvine

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00237562

Brief Title

Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

Official Title

Single Visit Cervical Cancer Prevention Program

Study Type

Interventional

2. Study Status

Record Verification Date

October 2005

Overall Recruitment Status

Completed

Study Start Date

July 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, Irvine

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

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

Detailed Description

Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Large loop electrosurgical excision

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberto Manetta, MD

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Irvine

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16264159

Citation

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.

Results Reference

result

Learn more about this trial

Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

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