Clinical trial · Interventional
Point-of-Care Ultraviolet Microscopy for Cervical Cancer Screening
Point of Care Ultraviolet Microscopy as a Novel Screening Method for Cervical Dysplasia
NCT05899647CI-TRIAL-00071875unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultraviolet Microscopic Analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enrolled Patients
- description
- Consented patients who have had an additional Pap sample taken at their visit.
- interventionNames
- Diagnostic Test: Ultraviolet Microscopic Analysis
Primary outcomes (1)
- measure
- Cellular features
- timeFrame
- One year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients presenting for cervical cancer screening. * Patients presenting for follow-up for positive cervical cancer screening. Exclusion Criteria: * Patients who do not, or no longer, require cervical cancer screening
References
Publications (0)
Data not yet available
No reference posted for this study.