Clinical trial · Observational
Investigating the Clinical Utility of the MDS
Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma
NCT03109327CI-TRIAL-00048381OMS002_UKcompletedClinicalTrials.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 purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Moles | — | UNRESOLVED | — |
| Skin Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melanoma Detection System -MDS | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Urgent Excision
- description
- Subjects with moles suspicious of melanoma and are scheduled for an urgent excision.
- interventionNames
- Diagnostic Test: Melanoma Detection System -MDS
- label
- Non-urgent Excision
- description
- Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision.
- interventionNames
- Diagnostic Test: Melanoma Detection System -MDS
Primary outcomes (1)
- measure
- Utility of the MDS in determining urgent or non-urgent excision of moles.
- timeFrame
- 1 day
- description
- The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Lesion has one or more of the ABCDE features and is recommended for excision. 2. Lesion has at least 1 cm of skin around it that is accessible to the MDS. 3. Patient is at least 18 years old. 4. Patient is capable of giving written informed consent. 5. Lesion is scheduled for primary excision. Exclusion Criteria: 1. Lesion is less than one centimetre from the eyes. 2. Lesion is on the palms of the hands or soles of the feet. 3. Lesion is mucosal. 4. Lesion is ulcerated. 5. Patient is pregnant. 6. Low patient study procedure compliance. 7. Patient who is mentally or physically unable to comply with all aspects of the study. 8. Patient is undergoing chemotherapy. 9. Patient has known sensitivity to fluorescent dyes. 10. Ink marking on or adjacent to lesion. 11. Lesions larger than 20mm or too large to allow imaging.
References
Publications (0)
Data not yet available
No reference posted for this study.