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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06661577




Registration number
NCT06661577
Ethics application status
Date submitted
23/10/2024
Date registered
28/10/2024

Titles & IDs
Public title
An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.
Scientific title
A Multi-Centre Observational Study For The Collection Of A Raman Spectral Database Using The LumAssure Device In Adult Participants Undergoing Dermatological Assessment Of Skin Conditions
Secondary ID [1] 0 0
HDEC 21297
Secondary ID [2] 0 0
HDEC21297
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancers - Basal Cell Carcinoma 0 0
Skin Cancers - Squamous Cell Carcinoma 0 0
Melanoma of Skin 0 0
Inflammatory Dermatoses 0 0
Acral Melanoma 0 0
Benign Skin Nevus 0 0
Benign Skin Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Malignant melanoma
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Healthy volunteers - Male and female healthy volunteers, aged 18 years or over, attending a study specific skin check appointment, without a diagnosis or histology of malignancies.

SOC Patients - Participants attending a standard of care medical appointment at a skin clinic, a plastic surgery or a general practitioner for assessment, diagnosis and/or potential excision of a skin condition, With confirmatory medical practitioner diagnosis, and where appropriate confirmatory histological analysis of excised tissues
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers
Timepoint [1] 0 0
Day 1, baseline, 12 months
Secondary outcome [1] 0 0
Number of participants with adverse events and descriptions of adverse events
Timepoint [1] 0 0
Day 1, baseline, 12 months

Eligibility
Key inclusion criteria
* Able to provide informed consent
* Male or female aged 18 years or over.
* Willing to undergo a LumAssure device measurement on at least 1 skin condition
* (For Standard of Care patients): are undergoing a skin examination and/or tissue excision by a qualified specialist
* (For Healthy volunteers): are attending a skin check at a study clinic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Tattoo on the skin condition to be measured
* Skin conditions on or directly around the eye area

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
13/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Auckland UniServices Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Counties Manukau Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michel K Nieuwoudt, PhD
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michel K Nieuwoudt, PhD
Address 0 0
Country 0 0
Phone 0 0
+64210378601
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06661577