Brief Title
Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit
Official Title
Single Visit Cervical Cancer Prevention Program
Brief 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
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.
Study Phase
Phase 3
Study Type
Interventional
Condition
Cervical Intraepithelial Neoplasia
Intervention
Large loop electrosurgical excision
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Start Date
July 1999
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Alberto Manetta, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00237562
Organization ID
R01CA076501
Study Sponsor
University of California, Irvine
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Alberto Manetta, MD, Principal Investigator, University of California, Irvine
Verification Date
October 2005