Investigating the Clinical Utility of the MDS
OMS002_UK
1 other identifier
observational
250
1 country
1
Brief Summary
The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedNovember 19, 2020
November 1, 2020
2.6 years
March 8, 2017
November 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Does the MDS have an additive value to clinical evaluation of moles.
1 day
Other Outcomes (1)
User feedback for clinical use of the MDS in the clinical management of moles.
1 day
Study Arms (2)
Urgent Excision
Subjects with moles suspicious of melanoma and are scheduled for an urgent excision.
Non-urgent Excision
Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision.
Interventions
Imaging of lesion using the MDS test.
Eligibility Criteria
Subjects referred to a specialist for possible presence of melanoma in skin lesions.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orlucent, Inclead
- NHS Lanarkshirecollaborator
- NHS Taysidecollaborator
- NHS Greater Glasgow and Clydecollaborator
- University Hospitals, Leicestercollaborator
- University of Dundeecollaborator
Study Sites (1)
NHS Lanarkshire, Monklands Hospital
Airdrie, ML60JS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
April 12, 2017
Study Start
April 1, 2018
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
November 19, 2020
Record last verified: 2020-11