Feasibility of the Management of Severe Cervical Dysplasi... | NCT00237562

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

NCT00237562

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

May 5, 2006Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Cervical Intraepithelial Neoplasia

Interventions

Large loop electrosurgical excision

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 10, 2005

First Submission Date that Met QC Criteria

Oct 10, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2006

Last Update Posted Date

May 5, 2006Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Large loop electrosurgical excision	Procedure

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alberto Manetta, MD	University of California, Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine		Orange	California	92868	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16264159	Result	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.

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases