Focal Ablation of Cervical Precancer

NCT ID: NCT01709773

Last Updated: 2018-02-20

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-17

Study Completion Date

2014-05-26

Brief Summary

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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

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Conditions

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High-grade Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Focal treatment arm

Group Type EXPERIMENTAL

Focal treatment

Intervention Type PROCEDURE

Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure

Interventions

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Focal treatment

Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Smith-McCune, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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12503

Identifier Type: -

Identifier Source: org_study_id

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