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

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

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California, Irvine

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Large loop electrosurgical excision

Procedure

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Single Visit Cervical Cancer Prevention Program

Important dates

Study start: 1999
First posted: Oct 12, 2005
Registry last updated: May 5, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed