Focal Ablation of Cervical Precancer | NCT01709773

Studies
Focal Ablation of Cervical Precancer

NCT01709773

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Feb 20, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

High-grade Cervical Intraepithelial Neoplasia

Interventions

Focal treatment

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

Feb 2018

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

Jan 17, 2013Actual

Primary Completion Date

Apr 11, 2014Actual

Completion Date

May 26, 2014Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 16, 2012

First Posted Date

Oct 18, 2012Estimated

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

Feb 16, 2018

Last Update Posted Date

Feb 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be calculated.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Focal treatment arm	Experimental		Procedure: Focal treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Focal treatment	Procedure	Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure	Focal treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia		six months

Secondary Outcomes

Measure	Description	Time Frame
Safety of focal treatment	Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).	six months
Acceptability of focal treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 21-45 yo
Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3
Satisfactory colposcopy, i.e., the entire transformation zone is visible
Lesion occupying <= 2 quadrants of the cervix.

Exclusion Criteria:

Unsatisfactory colposcopy.
Colposcopic lesion extending into the endocervical canal beyond colposcopic visualization.
Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
Suspicion for invasive cancer on colposcopic exam.
Glandular dysplasia or atypical glandular cells on cytology.
Unreliable for follow-up.
Immunosuppression (HIV, transplant recipient, etc.)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Smith-McCune, MD, PhD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94109	United States