Clinical trial · Interventional
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
NCT03050788CI-TRIAL-00047906completedN/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)
The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.
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 |
|---|---|---|---|
| Kaposi Sarcoma | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smartphone confocal microscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Smartphone confocal microscopy imaging
- description
- Subject's skin lesion will be imaged with the smartphone confocal microscopy.
- interventionNames
- Device: Smartphone confocal microscopy
Primary outcomes (1)
- measure
- Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy
- timeFrame
- Approximately 20 minutes (10 minutes for in vivo imaging)
- description
- Confocal microscopy images obtained from the skin lesion will be compared with the corresponding histologic images. Diagnostic accuracy will be tested. No clinical decisions will be made based on confocal microscopy images.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: i. ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye. Exclusion Criteria: i. Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.
References
Publications (0)
Data not yet available
No reference posted for this study.