Skip to main content
OpenTrials
Completed

NCT Number: NCT03109327

Investigating the Clinical Utility of the MDS

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Lesion Melanoma Moles Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Lanarkshire, Monklands Hospital

Airdrie, ML60JS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lesion has one or more of the ABCDE features and is recommended for excision.
  • Lesion has at least 1 cm of skin around it that is accessible to the MDS.
  • Patient is at least 18 years old.
  • Patient is capable of giving written informed consent.
  • Lesion is scheduled for primary excision.

Exclusion criteria

  • Lesion is less than one centimetre from the eyes.
  • Lesion is on the palms of the hands or soles of the feet.
  • Lesion is mucosal.
  • Lesion is ulcerated.
  • Patient is pregnant.
  • Low patient study procedure compliance.
  • Patient who is mentally or physically unable to comply with all aspects of the study.
  • Patient is undergoing chemotherapy.
  • Patient has known sensitivity to fluorescent dyes.
  • Ink marking on or adjacent to lesion.
  • Lesions larger than 20mm or too large to allow imaging.

Treatment and study plan

Melanoma Detection System -MDS

Diagnostic Test

Imaging of lesion using the MDS test.

Other names: MDS

Primary outcomes

  1. Utility of the MDS in determining urgent or non-urgent excision of moles.

    Time frame: 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 outcomes

  1. Does the MDS have an additive value to clinical evaluation of moles.

    Time frame: 1 day

    Does the MDS system provide superior results when compared to clinical evaluation.

Other outcomes

  1. User feedback for clinical use of the MDS in the clinical management of moles.

    Time frame: 1 day

    To gain feedback from users on how to best incorporate the MDS testing procedure in the clinical setting.

Sponsors and collaborators

Lead sponsor

Orlucent, Inc

Industry

Collaborators

  • NHS Greater Glasgow and Clyde
  • NHS Lanarkshire
  • NHS Tayside
  • University Hospitals, Leicester
  • University of Dundee

Registry information

Official study title

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

Acronym: OMS002_UK

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.