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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03109327

Acronym

OMS002_UK

Enrollment

250

Registered

2017-04-12

Start date

2018-04-01

Completion date

2020-10-30

Last updated

2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Moles, Skin Lesion

Brief summary

The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

Detailed description

The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.

Interventions

DIAGNOSTIC_TESTMelanoma Detection System -MDS

Imaging of lesion using the MDS test.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Utility of the MDS in determining urgent or non-urgent excision of moles.	1 day	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.

Secondary

Measure	Time frame	Description
Does the MDS have an additive value to clinical evaluation of moles.	1 day	Does the MDS system provide superior results when compared to clinical evaluation.

Other

Measure	Time frame	Description
User feedback for clinical use of the MDS in the clinical management of moles.	1 day	To gain feedback from users on how to best incorporate the MDS testing procedure in the clinical setting.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026