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OMS002_UK: Investigating the Clinical Utility of the MDS

Sponsor
Orlucent, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT03109327
Collaborator
NHS Lanarkshire (Other), NHS Tayside (Other), NHS Greater Glasgow and Clyde (Other), University Hospitals, Leicester (Other), University of Dundee (Other)
250
Enrollment
1
Location
31
Actual Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NHS Lanarkshire, Monklands Hospital Airdrie United Kingdom ML60JS

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Orlucent, Inc
    ClinicalTrials.gov Identifier:
    NCT03109327
    Other Study ID Numbers:
    • OMS002_UK
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Nov 19, 2020