MedDataX Logo

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

NCT ID: NCT00237562

Last Updated: 2006-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Intraepithelial Neoplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Large loop electrosurgical excision

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alberto Manetta, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Irvine

Orange, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16264159 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA076501

Identifier Type: NIH

Identifier Source: org_study_id

View Link