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OpenTrials
Completed

NCT Number: NCT01709773

Focal Ablation of Cervical Precancer

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.

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Key information

Conditions

High-grade Cervical Intraepithelial Neoplasia

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Focal treatment

Procedure

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

Primary outcomes

  1. Six-month recurrence rate of high-grade cervical intraepithelial neoplasia

    Time frame: six months

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Focal Ablation of High-grade Cervical Intraepithelial Neoplasia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2012
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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