Investigating the Clinical Utility of the MDS (OMS002_UK)

November 17, 2020 updated by: Orlucent, Inc

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: 1 day
To gain feedback from users on how to best incorporate the MDS testing procedure in the clinical setting.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlucent, Inc

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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