Cervical Intraepithelial NeoplasiaNCT01349621
Clinical Evaluation of Polarized Light Assisted Colposcopy
An observational study of Cervical Intraepithelial Neoplasia, run by Augusta University at 1 site in United States.
Trial summary
This is a prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examination. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 2014
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women with a previously detected abnormal cervical cytology or other indication for colposcopy
Who may be able to join
- Subject is female, 18 years or older
- Subject has previously detected abnormal cervical cytology or other indication for colposcopy
- Subject fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent
Who cannot join
- Subject is pregnant or may be pregnant
- Subject has known allergy to acetic acid
- Subject has thrombocytopenia or other coagulation disorder that would contraindicate obtaining multiple cervical biopsies
- Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
- Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate
- Subject has clinical evidence of gross purulent cervicitis
- Subject has a recent history of acute cervicitis
- Subject does not have an intact cervix uteri or has more than one cervix uteri
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
This is a prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examination. His/her impression of the exam will be noted and if necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy using a polarized light. His/her impression of the exam will be noted and a biopsy specimen will be obtained if necessary.
This study is designed to test the hypothesis that polarized light colposcopy is more sensitive and more specific than standard, un-polarized light colposcopy.
Read the detailed description
Women scheduled for a colposcopic examination at GRU or CerviCusco were asked to participate in the study. Interested patients read and signed an IRB-approved Informed Consent Document (ICD) that described the study and their potential involvement. The study coordinator read and or translated the ICD to women who spoke languages other than English or Spanish (i.e. Quechua).
Pertinent disease specific demographic information was collected from each patient. Following insertion of a vaginal speculum and a one minute application of 5% acetic acid, polarized and non-polarized high resolution digital RGB images were taken of the ectocervix. Thereafter, non-polarized light colposcopy was performed as standard of care. The colposcopist derived a colposcopic impression and indicated whether a biopsy was necessary. So as not to compromise the next examination, Lugol's Iodine was not applied. Then, a polarized light colposcopy was performed. As before, the colposcopist derived an impression, indicated whether a biopsy was necessary and annotated the site of pending biopsy. Then if indicated, a minimum of one cervical biopsy was obtained from the area(s) representing the most severe colopscopic changes as seen during the non-polarized exam. The exact biopsy site was annotated.
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Abnormal Pap results, Colposcopy
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard and polarized light colposcopy | Standard and polarized light colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated.
We will examine 300 women scheduled for colposcopy using unpolarized and polarized light. To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated. We anticipate that it will take approximately 8-10 months to enroll 300 subjects.
Measured: 8-10 months
Secondary outcomes (1)
We will determine the differences in the severity of cervical neoplasia between biopsies taken using polarized and unpolarized light using a Bowker's test of symmetry.
Test the hypothesis that rates of cervical neoplasia severity detected by polarized colposcopy are greater and unpolarized colposcopy.
Measured: 8-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daron Ferris, Augusta University
- Investigators
- Daron Ferris, MD, Principal investigator, Geogia Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349621
- Sponsor's protocol ID
- CA156166
- Other IDs
- 1R21CA156166-01A1
- Status last verified
- Sep 2012
- First submitted
- 5 May 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Polarized Light Assisted Colposcopy
- ClinicalTrials.gov ID
- NCT01349621
- Acronym / sponsor ID
- CA156166
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Abnormal Pap results, Colposcopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 May 2011 (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 prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examination. His/her impression of the exam will be noted and if necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy using a polarized light. His/her impression of the exam will be noted and a biopsy specimen will be obtained if necessary.
This study is designed to test the hypothesis that polarized light colposcopy is more sensitive and more specific than standard, un-polarized light colposcopy.
Detailed description
Women scheduled for a colposcopic examination at GRU or CerviCusco were asked to participate in the study. Interested patients read and signed an IRB-approved Informed Consent Document (ICD) that described the study and their potential involvement. The study coordinator read and or translated the ICD to women who spoke languages other than English or Spanish (i.e. Quechua).
Pertinent disease specific demographic information was collected from each patient. Following insertion of a vaginal speculum and a one minute application of 5% acetic acid, polarized and non-polarized high resolution digital RGB images were taken of the ectocervix. Thereafter, non-polarized light colposcopy was performed as standard of care. The colposcopist derived a colposcopic impression and indicated whether a biopsy was necessary. So as not to compromise the next examination, Lugol's Iodine was not applied. Then, a polarized light colposcopy was performed. As before, the colposcopist derived an impression, indicated whether a biopsy was necessary and annotated the site of pending biopsy. Then if indicated, a minimum of one cervical biopsy was obtained from the area(s) representing the most severe colopscopic changes as seen during the non-polarized exam. The exact biopsy site was annotated.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard and polarized light colposcopy | – | –Standard and polarized light colposcopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women with a previously detected abnormal cervical cytology or other indication for colposcopy
Key inclusion criteria (3 listed)
- Subject is female, 18 years or older
- Subject has previously detected abnormal cervical cytology or other indication for colposcopy
- Subject fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent
Key exclusion criteria (8 listed)
- Subject is pregnant or may be pregnant
- Subject has known allergy to acetic acid
- Subject has thrombocytopenia or other coagulation disorder that would contraindicate obtaining multiple cervical biopsies
- Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
- Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated.
Time frame: 8-10 months
We will examine 300 women scheduled for colposcopy using unpolarized and polarized light. To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated. We anticipate that it will take approximately 8-10 months to enroll 300 subjects.
1 secondary outcome
We will determine the differences in the severity of cervical neoplasia between biopsies taken using polarized and unpolarized light using a Bowker's test of symmetry.
Time frame: 8-10 months
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 10 Mar 2015.
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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.
Daron Ferris, MD principal investigator
Geogia Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia, run by Augusta University 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 3 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 10 Mar 2015. 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?
To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated. (time frame: 8-10 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 10 Mar 2015.