High-grade Cervical Intraepithelial NeoplasiaNCT01709773
Focal Ablation of Cervical Precancer
A study testing Focal treatment in people with High-grade Cervical Intraepithelial Neoplasia, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- High-grade Cervical Intraepithelial Neoplasia
- What is being tested?
- Focal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2013to 26 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94109
About this study
Official title: 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.
- Being tested
- Focal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal treatmentProcedure or surgery
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
| Study group | Role | What they receive |
|---|---|---|
| Focal treatment arm | Experimental | Not described Receives: Procedure: Focal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
Measured: six months
Secondary outcomes (3)
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).
Measured: six months
Acceptability of focal treatment
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.
Measured: six months
Feasibility of focal treatment
Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study start17 Jan 2013
- Primary completion11 Apr 2014
- Study completion26 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Smith-McCune, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709773
- Sponsor's protocol ID
- 12503
- Status last verified
- Feb 2018
- First submitted
- 15 Oct 2012
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT01709773
- Acronym / sponsor ID
- 12503
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 17 Jan 2013 (actual)
- Primary completion
- 11 Apr 2014 (actual)
- Study completion
- 26 May 2014 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal treatment arm | Experimental | Procedure: Focal treatment |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal treatmentFocal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure | Procedure or surgery | Focal treatment arm |
Primary outcome
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
Time frame: six months
3 secondary outcomes
Safety of focal treatment
Time frame: six months
Acceptability of focal treatment
Time frame: six months
Feasibility of focal treatment
Time frame: enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Smith-McCune, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal treatment in people with High-grade Cervical Intraepithelial Neoplasia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.