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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Single Visit Cervical Cancer Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237562
• Other study ID #: R01CA076501
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2005
• Last updated: May 4, 2006
• Start date: July 1999

Study information

• Verified date: October 2005
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;

2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;

3. Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);

4. Determine satisfaction and compare it between women assigned to the SVP and the UCP;

5. Determine the cost-effectiveness and compare it between the SVP and UCP

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Procedure:
• Large loop electrosurgical excision

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation