Cervical CancerNCT05899647
Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening
A study testing Ultraviolet Microscopic Analysis in people with Cervical Cancer, run by University of Arizona at 1 site in United States.
Trial summary
This study aims to determine the image features of cervical cells, as measured via ultraviolet microscopy, that would constitute a positive screening and a negative screening result for cervical dysplasia, a precursor to cervical cancer, as measured against liquid-based Papanicolaou testing. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Ultraviolet Microscopic Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to Sep 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting for cervical cancer screening.
- Patients presenting for follow-up for positive cervical cancer screening.
Who cannot join
- Patients who do not, or no longer, require cervical cancer screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center
Tucson, Arizona, 85719
About this study
Official title: Point of Care Ultraviolet Microscopy as a Novel Screening Method for Cervical Dysplasia
This study aims to determine the image features of cervical cells, as measured via ultraviolet microscopy, that would constitute a positive screening and a negative screening result for cervical dysplasia, a precursor to cervical cancer, as measured against liquid-based Papanicolaou testing.
Read the detailed description
The study population will consist of patients presenting to one of the three outpatient gynecology clinics within the Banner University Medical Center system for either a routine or follow up cervical cancer screening. Eligible subjects will be informed of the study and asked to consent to participate in accordance with standard informed consent protocol.
The subject will undergo a Papanicolaou screening test, using both a spatula and a cytobrush and collected in a Thinprep specimen container according to the manufacturer's instructions. This specimen will be used for standard-of-care cytology. A second specimen will then be obtained in an identical fashion, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy.
The second specimen will be taken from the clinic for processing in preparation for UV microscopy. A sample of the specimen will be smeared onto a UV slide and images taken. The UV images will be then analyzed to extract the following features for determining the stage of cervical lesion:
- Cellularity: The density of cells in the sample. A high cellularity indicates an abnormal growth of cells.
- Nuclear features: The size and shape of the nuclei in the cells. Abnormal nuclear features, such as enlarged nuclei or irregular chromatin distribution, can indicate the presence of a cervical lesion.
- Cytoplasmic features: The appearance of the cytoplasm in the cells. Abnormal cytoplasmic features, such as vacuolation or hyperchromasia, can indicate the presence of a cervical lesion.
- Cellular architecture: The organization and arrangement of the cells in the sample. Abnormal cellular architecture, such as loss of polarity or crowding of cells, can indicate the presence of a cervical lesion.
A second subject arm will consist of patients presenting to colposcopy clinic for colposcopy due to LSIL or HSIL findings on a screening Pap test. Subjects with test results of ASCUS or ASC-H will be excluded. A cervical cytology specimen will be taken from these subjects using both a spatula and a cytobrush, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy in a manner identical to the second specimen processing described above. Participants will then undergo colposcopy according to the standard of care based upon their prior cytology results.
- Conditions
- Cervical Cancer
- Being tested
- Ultraviolet Microscopic Analysis
- Keywords
- Screening, ultraviolet microscope, cervical dysplasia, Pap smear
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet Microscopic AnalysisDiagnostic test
Data to be collected from subjects at the time of their clinical visit; or upon chart review by the research team; will include demographic information, whether the subject is presenting for a routine screen or for a follow-up, and the subject's most recent cervical cytology result. Data to be collected from the standard-of-care cytology will include the cytologic diagnosis and the presence or absence of human papilloma virus (HPV), if applicable based on the subject's age. The Pap results of each subject will be reviewed and classified as "screen negative" (NIL), "screen positive" (LSIL, HSIL), or "indeterminate" (ASCUS, ASC-H). Subjects with a positive screen, or an indeterminate result, who undergo colposcopy will have their colposcopy results recorded as well. The UV microscopy imaging features will be coded and collected.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Patients | Experimental | Consented patients who have had an additional Pap sample taken at their visit. Receives: Diagnostic Test: Ultraviolet Microscopic Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular features
The extracted features from the UV microscopic analysis will be compared with the results from the standard-of-care cytology. Gaussian distributions will be plotted for each feature, with a separate distribution plotted for patients who screen positive and who screen negative based on standard-of-care cytology results. Combinations of UV microscopy features compared to the standard-of-care cytology results; and, if applicable, their colposcopy results; will be recorded and plotted as well. Areas of overlap between these distributions will be used to select an appropriate threshold value, with a target false negative rate of 14% or better
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start27 Nov 2023
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
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 University of ArizonaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Dudick, University of Arizona
- Investigators
- Steven J Dudick, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899647
- Sponsor's protocol ID
- STUDY00003019
- Status last verified
- Nov 2023
- First submitted
- 1 Jun 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultraviolet Microscopy as a Novel Screening Method for Cervical Dysplasia
- ClinicalTrials.gov ID
- NCT05899647
- Acronym / sponsor ID
- STUDY00003019
- Conditions
- Cervical Cancer
- Keywords
- Screening, ultraviolet microscope, cervical dysplasia, Pap smear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- 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 aims to determine the image features of cervical cells, as measured via ultraviolet microscopy, that would constitute a positive screening and a negative screening result for cervical dysplasia, a precursor to cervical cancer, as measured against liquid-based Papanicolaou testing.
Detailed description
The study population will consist of patients presenting to one of the three outpatient gynecology clinics within the Banner University Medical Center system for either a routine or follow up cervical cancer screening. Eligible subjects will be informed of the study and asked to consent to participate in accordance with standard informed consent protocol.
The subject will undergo a Papanicolaou screening test, using both a spatula and a cytobrush and collected in a Thinprep specimen container according to the manufacturer's instructions. This specimen will be used for standard-of-care cytology. A second specimen will then be obtained in an identical fashion, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy.
The second specimen will be taken from the clinic for processing in preparation for UV microscopy. A sample of the specimen will be smeared onto a UV slide and images taken. The UV images will be then analyzed to extract the following features for determining the stage of cervical lesion:
- Cellularity: The density of cells in the sample. A high cellularity indicates an abnormal growth of cells.
- Nuclear features: The size and shape of the nuclei in the cells. Abnormal nuclear features, such as enlarged nuclei or irregular chromatin distribution, can indicate the presence of a cervical lesion.
- Cytoplasmic features: The appearance of the cytoplasm in the cells. Abnormal cytoplasmic features, such as vacuolation or hyperchromasia, can indicate the presence of a cervical lesion.
- Cellular architecture: The organization and arrangement of the cells in the sample. Abnormal cellular architecture, such as loss of polarity or crowding of cells, can indicate the presence of a cervical lesion.
A second subject arm will consist of patients presenting to colposcopy clinic for colposcopy due to LSIL or HSIL findings on a screening Pap test. Subjects with test results of ASCUS or ASC-H will be excluded. A cervical cytology specimen will be taken from these subjects using both a spatula and a cytobrush, labeled with a deidentified code unique to the subject, and held under refrigeration pending microscopy in a manner identical to the second specimen processing described above. Participants will then undergo colposcopy according to the standard of care based upon their prior cytology results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Patients | Experimental | Diagnostic Test: Ultraviolet Microscopic AnalysisConsented patients who have had an additional Pap sample taken at their visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting for cervical cancer screening.
- Patients presenting for follow-up for positive cervical cancer screening.
Key exclusion criteria (1 listed)
- Patients who do not, or no longer, require cervical cancer screening
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 |
|---|---|---|
| Ultraviolet Microscopic AnalysisData to be collected from subjects at the time of their clinical visit; or upon chart review by the research team; will include demographic information, whether the subject is presenting for a routine screen or for a follow-up, and the subject's most recent cervical cytology result. Data to be collected from the standard-of-care cytology will include the cytologic diagnosis and the presence or absence of human papilloma virus (HPV), if applicable based on the subject's age. The Pap results of each subject will be reviewed and classified as "screen negative" (NIL), "screen positive" (LSIL, HSIL), or "indeterminate" (ASCUS, ASC-H). Subjects with a positive screen, or an indeterminate result, who undergo colposcopy will have their colposcopy results recorded as well. The UV microscopy imaging features will be coded and collected. | Diagnostic test | Enrolled Patients |
Primary outcome
Cellular features
Time frame: One year
The extracted features from the UV microscopic analysis will be compared with the results from the standard-of-care cytology. Gaussian distributions will be plotted for each feature, with a separate distribution plotted for patients who screen positive and who screen negative based on standard-of-care cytology results. Combinations of UV microscopy features compared to the standard-of-care cytology results; and, if applicable, their colposcopy results; will be recorded and plotted as well. Areas of overlap between these distributions will be used to select an appropriate threshold value, with a target false negative rate of 14% or better
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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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.
Steven J Dudick, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet Microscopic Analysis in people with Cervical Cancer, run by University of Arizona 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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?
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?
Cellular features (time frame: One year). 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 30 Nov 2023.