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

This study has been completed.

Sponsors and Collaborators:	University of California, Irvine National Cancer Institute (NCI)
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00237562

Purpose

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

Condition	Intervention	Phase
Cervical Intraepithelial Neoplasia	Procedure: Large loop electrosurgical excision	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Single Visit Cervical Cancer Prevention Program

Further study details as provided by University of California, Irvine:

Study Start Date:

July 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237562

Locations

United States, California
University of California, Irvine
Orange, California, United States, 92868

Sponsors and Collaborators

University of California, Irvine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Alberto Manetta, MD

University of California, Irvine

More Information

Publications of Results:

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.

Study ID Numbers:	R01 CA76501
Study First Received:	October 10, 2005
Last Updated:	May 4, 2006
ClinicalTrials.gov Identifier:	NCT00237562
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Cervical intraepithelial neoplasia
Carcinoma in Situ
Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009