Investigating the Clinical Utility of the MDS

Melanoma Clinical Trial

— OMS002_UK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109327
• Other study ID #: OMS002_UK
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Orlucent, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Moles
• Skin Lesion

Intervention

Diagnostic Test:
• Melanoma Detection System -MDS
Imaging of lesion using the MDS test.

Locations

Country	Name	City	State
United Kingdom	NHS Lanarkshire, Monklands Hospital	Airdrie

Sponsors (6)

Lead Sponsor	Collaborator
Orlucent, Inc	NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Tayside, University Hospitals, Leicester, University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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