Cervical CancerNCT02338141
Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women
A study testing Portable colposcopy (Cerviscope) and Conventional colposcopy (Wallach Zoomscope) in people with Cervical Cancer and Human Papillomavirus, run by Duke University at 1 site in Haiti.
Trial summary
This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Human Papillomavirus, Human Immunodeficiency Virus
- What is being tested?
- Portable colposcopy (Cerviscope) and Conventional colposcopy (Wallach Zoomscope)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteHaiti
- Study dates
- Aug 2015to Feb 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 25-60 years old
- Pre-tested as positive for human papillomavirus (HPV)
Who cannot join
- Pre-tested as negative for human papillomavirus (HPV)
- Pregnant at time of enrollment
- Prior hysterectomy
- < 25 or > 60 years old
- Male
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti
This study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.
Read the detailed description
This research is a randomized, prospective trial designed to evaluate the value of magnification in making a diagnosis of high grade intraepithelial lesions of the cervix. The overall goal is to evaluate a cervical cancer screening protocol that provides the highest level of care possible for low-resource communities and hard-to-reach areas. Currently, a national cervical cancer screening and diagnosis program does not exist within Haiti.
All women meeting inclusion criteria will be randomized to portable (8x magnification with the Cerviscope) or conventional (25x magnification) colposcopy. After application of acetic acid to the cervix, the physician will record naked eye observations of the cervix by: 1) recording the location of all white lesions; 2) describing the vascular pattern; and 3) stating his/her clinical impression of a diagnosis. The physician will then follow-up with use of either the portable or the conventional colposcope to: 1) record the location of all white lesions; 2) describe the vascular pattern; and 3) state a clinical impression of diagnosis. Women will have biopsies in all four quadrants of the cervix even if no cervical lesions are seen to evaluate the accuracy of the visualization techniques against the gold standard of biopsy pathologic results. Treatment options will be dictated by biopsy results.
Biopsy material will also be evaluated for specific HPV genotype using lab-based measures. Results of these genotypes will be compared between women with high-grade disease vs. low-grade disease and in the subset of women with HIV compared to the HIV-negative population.
- Being tested
- Portable colposcopy (Cerviscope), Conventional colposcopy (Wallach Zoomscope)
- Keywords
- cervical cancer, colposcopy, human papillomavirus, human immunodeficiency virus
- Medical subject headings
- Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable colposcopy (Cerviscope)Device
Also called Cerviscope
HPV-positive women will be evaluated with portable colposcopy (with a novel portable colposcope known as the Cerviscope) after visual inspection with acetic acid and prior to biopsy in the experimental group.
Conventional colposcopy (Wallach Zoomscope)Device
HPV-positive women will be evaluated with conventional colposcopy (with the Wallach Zoomscope) after visual inspection with acetic acid and prior to biopsy per usual standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Portable colposcopy | Experimental | Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid Receives: Device: Portable colposcopy (Cerviscope) |
| Conventional colposcopy | Active comparator | Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid Receives: Device: Conventional colposcopy (Wallach Zoomscope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
The number of correct diagnoses of HSIL by eventual pathologic diagnosis will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Measured: Point-of-care (at time of examination, approximately one hour)
Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Rates of detection of these abnormal vascular patterns will be compared between 8x magnification (Cerviscope) and 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and between both and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Measured: Point-of-care (at time of examination, approximately one hour)
Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Concordance between these visualized vascular patterns and eventual pathologic diagnosis from biopsy will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Measured: Point-of-care (at time of examination, approximately one hour)
Secondary outcomes (2)
Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
HPV genotypes will be performed for patients and reported as percentages isolated for the differing lesion grades of HSIL vs. non-HSIL cervical lesions based on genotype results and correlation with biopsy results.
Measured: Point-of-care (at time of examination, approximately one hour)
Prevalence of HPV genotypes by HIV status
HPV genotypes will be performed for patients and reported as percentages isolated for HIV positive and negative women based on genotype results after HIV status is determined. This will be further reported by HIV status in women with different lesion severities.
Measured: Point-of-care (at time of examination, approximately one hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Funding unavailable to perform study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David K Walmer, MD, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338141
- Sponsor's protocol ID
- Pro00055627
- Status last verified
- Nov 2016
- First submitted
- 30 Dec 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Accuracy of Portable Colposcopy and Prevalent HPV Genotypes Among HIV Positive Women in Haiti
- ClinicalTrials.gov ID
- NCT02338141
- Acronym / sponsor ID
- Pro00055627
- Keywords
- cervical cancer, colposcopy, human papillomavirus, human immunodeficiency virus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable to perform study.
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Jan 2015 (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 study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.
Detailed description
This research is a randomized, prospective trial designed to evaluate the value of magnification in making a diagnosis of high grade intraepithelial lesions of the cervix. The overall goal is to evaluate a cervical cancer screening protocol that provides the highest level of care possible for low-resource communities and hard-to-reach areas. Currently, a national cervical cancer screening and diagnosis program does not exist within Haiti.
All women meeting inclusion criteria will be randomized to portable (8x magnification with the Cerviscope) or conventional (25x magnification) colposcopy. After application of acetic acid to the cervix, the physician will record naked eye observations of the cervix by: 1) recording the location of all white lesions; 2) describing the vascular pattern; and 3) stating his/her clinical impression of a diagnosis. The physician will then follow-up with use of either the portable or the conventional colposcope to: 1) record the location of all white lesions; 2) describe the vascular pattern; and 3) state a clinical impression of diagnosis. Women will have biopsies in all four quadrants of the cervix even if no cervical lesions are seen to evaluate the accuracy of the visualization techniques against the gold standard of biopsy pathologic results. Treatment options will be dictated by biopsy results.
Biopsy material will also be evaluated for specific HPV genotype using lab-based measures. Results of these genotypes will be compared between women with high-grade disease vs. low-grade disease and in the subset of women with HIV compared to the HIV-negative population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable colposcopy | Experimental | Device: Portable colposcopy (Cerviscope)Diagnostic evaluation with 8x magnification portable colposcopy after visual inspection with acetic acid |
| Conventional colposcopy | Active comparator | Device: Conventional colposcopy (Wallach Zoomscope)Diagnostic evaluation with standard 25x magnification conventional colposcopy after visual inspection with acetic acid |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- 25-60 years old
- Pre-tested as positive for human papillomavirus (HPV)
Key exclusion criteria (5 listed)
- Pre-tested as negative for human papillomavirus (HPV)
- Pregnant at time of enrollment
- Prior hysterectomy
- < 25 or > 60 years old
- Male
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 |
|---|---|---|
| Portable colposcopy (Cerviscope)Also: CerviscopeHPV-positive women will be evaluated with portable colposcopy (with a novel portable colposcope known as the Cerviscope) after visual inspection with acetic acid and prior to biopsy in the experimental group. | Device | Portable colposcopy |
| Conventional colposcopy (Wallach Zoomscope)HPV-positive women will be evaluated with conventional colposcopy (with the Wallach Zoomscope) after visual inspection with acetic acid and prior to biopsy per usual standard of care. | Device | Conventional colposcopy |
Primary outcome
Number of accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method
Time frame: Point-of-care (at time of examination, approximately one hour)
The number of correct diagnoses of HSIL by eventual pathologic diagnosis will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Detection rates of vascular patterns of high-grade cervical lesions in human papillomavirus positive women by visualization method
Time frame: Point-of-care (at time of examination, approximately one hour)
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Rates of detection of these abnormal vascular patterns will be compared between 8x magnification (Cerviscope) and 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and between both and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
Rate of concordance between vascular patterns indicative of high-grade squamous intraepithelial lesions and biopsy by visualization method
Time frame: Point-of-care (at time of examination, approximately one hour)
Vascular patterns differ in cervical lesions versus the normal cervix, with cervical lesion patterns often visible under magnification after the application of acetic acid. Concordance between these visualized vascular patterns and eventual pathologic diagnosis from biopsy will be compared between 8x magnification (Cerviscope), 25x magnification (Wallach Zoomscope, the standard for visualization in developed nations) and 1x magnification (visual inspection with acetic acid, the standard for visualization in low-resource settings).
2 secondary outcomes
Prevalence of human papillomavirus (HPV) genotypes by cervical lesion severity
Time frame: Point-of-care (at time of examination, approximately one hour)
Prevalence of HPV genotypes by HIV status
Time frame: Point-of-care (at time of examination, approximately one hour)
Results and safety
The study was stopped early (reason given: Funding unavailable to perform study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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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.
David K Walmer, MD, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable colposcopy (Cerviscope) and Conventional colposcopy (Wallach Zoomscope) in people with Cervical Cancer and Human Papillomavirus, run by Duke University at 1 site in Haiti.
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 5 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: stopped early, as of the sponsor's last update on 28 Apr 2017. 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 Haiti. 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 was stopped early (reason given: Funding unavailable to perform study.). Results are not available in the source record.
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 accurate high-grade squamous intraepithelial lesion (HSIL) diagnoses by visualization method (time frame: Point-of-care (at time of examination, approximately one hour)). The study lists 3 primary outcomes in all. 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 28 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.