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Focal Ablation of Cervical Precancer

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ClinicalTrials.gov Identifier: NCT01709773
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

October 15, 2012
October 18, 2012
February 20, 2018
January 17, 2013
April 11, 2014   (Final data collection date for primary outcome measure)
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia [ Time Frame: six months ]
Same as current
Complete list of historical versions of study NCT01709773 on ClinicalTrials.gov Archive Site
  • Safety of focal treatment [ Time Frame: six months ]
    Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).
  • Acceptability of focal treatment [ Time Frame: six months ]
    Participants will be asked to respond to a survey at enrollment and follow-up asking whether they are satisfied with focal treatment as an alternative method of treatment.
  • Feasibility of focal treatment [ Time Frame: enrollment ]
    Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
Same as current
Not Provided
Not Provided
 
Focal Ablation of Cervical Precancer
Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
High-grade Cervical Intraepithelial Neoplasia
Procedure: Focal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
Experimental: Focal treatment arm
Intervention: Procedure: Focal treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
40
May 26, 2014
April 11, 2014   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: Female
21 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01709773
12503
No
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Karen Smith-McCune, MD, PhD University of California, San Francisco
University of California, San Francisco
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP