High-grade Cervical Intraepithelial NeoplasiaNCT02220192
An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure
A study testing Focal LEEP in people with High-grade Cervical Intraepithelial Neoplasia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients. 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 LEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2016
- 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 years old
- Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic.
- Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix.
- Satisfactory (adequate) colposcopy.
- Lives within 100 miles of the University of Alabama at Birmingham.
Who cannot join
- Any suspicion for invasive cancer.
- Glandular abnormalities on cytology or histology.
- Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).
- Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
- Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives >100 miles away will be excluded due to concern for possible loss to follow-up.
- Immunosuppression (HIV positive, history of transplantation, lupus on immunosuppressive medication, etc.).
- Pregnancy.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
Read the detailed description
Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.
- Being tested
- Focal LEEP
- Keywords
- cervical neoplasia, cervix, high-grade dysplasia, LEEP (loop electrosurgical excision procedure), precancerous cells, colposcopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal LEEPProcedure or surgery
Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Focal LEEP | Experimental | All patients will undergo focal treatment of high-grade cervical intraepithelial neoplasia using LEEP. A two-week follow-up assessment will evaluate the side effects of the treatment and any unusual symptoms. This will be done through a phone survey. At six months a clinic visit is required to assess whether there are any precancerous cells of the patient's cervix. Receives: Procedure: Focal LEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of recurrent high-grade cervical intraepithelial neoplasia
Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
Measured: 6 months
Secondary outcomes (2)
Acceptability of focal LEEP procedure
A 15-minute questionnaire will be conducted by phone with the patient.
Measured: 2 weeks following focal LEEP procedure
Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia
A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.
Measured: Within 1 week following focal LEEP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionMar 2016
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 Alabama at BirminghamThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michelle Khan, University of Alabama at Birmingham
- Investigators
- Michelle J Khan, MD, MPH, Principal investigator, University of Alabama of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220192
- Sponsor's protocol ID
- F140613004 (UAB 1425)
- Other IDs
- 000344450-SP012
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
- ClinicalTrials.gov ID
- NCT02220192
- Acronym / sponsor ID
- F140613004 (UAB 1425)
- Keywords
- cervical neoplasia, cervix, high-grade dysplasia, LEEP (loop electrosurgical excision procedure), precancerous cells, colposcopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Aug 2014 (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 study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
Detailed description
Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal LEEP | Experimental | Procedure: Focal LEEPAll patients will undergo focal treatment of high-grade cervical intraepithelial neoplasia using LEEP. A two-week follow-up assessment will evaluate the side effects of the treatment and any unusual symptoms. This will be done through a phone survey. At six months a clinic visit is required to assess whether there are any precancerous cells of the patient's cervix. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 21-45 years old
- Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic.
- Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix.
- Satisfactory (adequate) colposcopy.
- Lives within 100 miles of the University of Alabama at Birmingham.
Key exclusion criteria (8 listed)
- Any suspicion for invasive cancer.
- Glandular abnormalities on cytology or histology.
- Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).
- Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
- Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives >100 miles away will be excluded due to concern for possible loss to follow-up.
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 LEEPFocal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy. | Procedure or surgery | Focal LEEP |
Primary outcome
Number of cases of recurrent high-grade cervical intraepithelial neoplasia
Time frame: 6 months
Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
2 secondary outcomes
Acceptability of focal LEEP procedure
Time frame: 2 weeks following focal LEEP procedure
Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia
Time frame: Within 1 week following focal LEEP procedure
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 6 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Michelle J Khan, MD, MPH principal investigator
University of Alabama of Birmingham
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 LEEP in people with High-grade Cervical Intraepithelial Neoplasia, run by University of Alabama at Birmingham 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 5 inclusion and 8 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 6 Apr 2016. 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?
Number of cases of recurrent high-grade cervical intraepithelial neoplasia (time frame: 6 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 6 Apr 2016.