Investigating the Clinical Utility of the MDS (OMS002_UK)

Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma

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

Study Overview

• Status: Completed
• Conditions: Melanoma; Skin Lesion; Moles
• Intervention / Treatment: Diagnostic test: 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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United Kingdom
  • Airdrie, United Kingdom, ML60JS
    • NHS Lanarkshire, Monklands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects referred to a specialist for possible presence of melanoma in skin lesions.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urgent Excision; Subjects with moles suspicious of melanoma and are scheduled for an urgent excision.	Diagnostic test: Melanoma Detection System -MDS; Imaging of lesion using the MDS test.; Other Names: MDS
Non-urgent Excision; Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision.	Diagnostic test: Melanoma Detection System -MDS; Imaging of lesion using the MDS test.; Other Names: MDS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orlucent, Inc
• Collaborators: University Hospitals, Leicester; NHS Tayside; University of Dundee; NHS Greater Glasgow and Clyde; NHS Lanarkshire

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: OMS002_UK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No