Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All IPD that underlie the results in a publication on the study will be made available. This includes information about the demographics, age, sex, Skin Fitzpatrick type and history of skin cancer of individual participants, which will be de-identified and compiled with the corresponding Raman spectral data into a dataset for data analysis for publication on the study. This dataset can be made available in a data repository upon reasonable request, as is required by many journals for publication.

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
6 months after completion of the observational study
Available to whom?
Report will be put into a web repository
Available for what types of analyses?
How or where can data be obtained?


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