Clinical trial · Observational
An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.
A Multi-Centre Observational Study For The Collection Of A Raman Spectral Database Using The LumAssure Device In Adult Participants Undergoing Dermatological Assessment Of Skin Conditions
- 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 is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. The measurements will provide data which will be used to establish spectral parameters for different skin conditions. Measurements will be benchmarked against diagnoses from medical specialists, and when available confirmed with histological data. The main question it aims to answer is : What is the accuracy, in terms of the area under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign skin conditions and skin cancers in adult males and females? Participants include males and females aged ≥18 years who are undergoing assessment of a skin condition (a lesion or rash) by a dermatologist, general practitioner, or plastic surgeon. Participants' attending the clinics will have their skin conditions examined by a clinician. The LumAssure device will then be used to measure Raman spectra of skin conditions and marked by the clinician. The Raman measurements will be benchmarked against skin condition assessment and, where available, diagnosis by a dermatologist, general practitioner, or a plastic surgeon, and for those lesions undergoing biopsy, confirmed with histology data.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acral Melanoma | Acral Melanoma | ONTOLOGY_EXACT | 0.90 |
| Benign Skin Nevus | Cutaneous Nevus | ALIAS | 0.90 |
| Benign Skin Tumor | Benign Skin Neoplasm | ALIAS | 0.90 |
| Inflammatory Dermatoses | — | UNRESOLVED | — |
| Melanoma of Skin | Cutaneous Melanoma | ALIAS | 0.90 |
| Skin Cancers - Basal Cell Carcinoma | — | UNRESOLVED | — |
| Skin Cancers - Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Healthy volunteers
- description
- Male and female healthy volunteers, aged 18 years or over, attending a study specific skin check appointment, without a diagnosis or histology of malignancies.
- label
- SOC Patients
- description
- Participants attending a standard of care medical appointment at a skin clinic, a plastic surgery or a general practitioner for assessment, diagnosis and/or potential excision of a skin condition, With confirmatory medical practitioner diagnosis, and where appropriate confirmatory histological analysis of excised tissues
Primary outcomes (1)
- measure
- Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers
- timeFrame
- Day 1, baseline, 12 months
- description
- The primary endpoint of the study will be the area under the ROC curve (AUCROC) of the LumAssure Raman device measurements for the differentiation between benign skin conditions and skin cancers. The primary aim is to collect sufficient LumAssure Raman device measurements of skin conditions to develop an algorithm which can help detect diagnosed skin conditions and malignancies determined via histological analysis of biopsied samples.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent * Male or female aged 18 years or over. * Willing to undergo a LumAssure device measurement on at least 1 skin condition * (For Standard of Care patients): are undergoing a skin examination and/or tissue excision by a qualified specialist * (For Healthy volunteers): are attending a skin check at a study clinic Exclusion Criteria: * Tattoo on the skin condition to be measured * Skin conditions on or directly around the eye area
References
Publications (0)
Data not yet available