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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03069846

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Diagnosing Melanoma, Squamous Cell Carcinoma and Basal Cell Carcinoma Using the Spectra-Scope
Scientific title
Collecting Spectral Signatures of Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Benign Lesions and Normal Tissues Using Spectra-Scope
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Cancer 0 0 0 0
Malignant melanoma

Study type
Description of intervention(s) / exposure
Treatment: Devices - Spectra-Scope

Experimental: Measurement using Spectra-Scope - Short pulsed Nd:YAG laser irradiation onto the skin lesion / measurement with Spectra-Scope

Treatment: Devices: Spectra-Scope
The Spectra-Scope consists of the light collection module and the spectral analysis module.
The light collection module is attached to the handpiece of short pulse Nd:YAG laser, and the analysis module is placed on the laser.
Each potential skin cancer site, which has previously been identified as requiring biopsy, should be assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots must be made before the scheduled biopsy.
All potentially cancerous lesions (or lesions that would usually undergo complete biopsy of the lesion or require follow up within three months) should be sampled. The Spectra-Scope will not provide a diagnosis at the time of sampling. Sites should record the spectra reported for each laser shot in the CRF.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin. - The aggregated emission spectra collected over a range of wavelengths from skin cells (skin cancer verses normal skin) irradiated with a commercial laser will be plotted to identify wavelengths with greatest spectra seperation.
Timepoint [1] 0 0
We plan to recruit 150 patients within a 3 month time frame.

Key inclusion criteria
1. Be aged 18 years or over;

2. Have at least one suspicious lesion that:

1. Is required to be biopsied for assessment of skin cancer (as assessed by at least
one dermatologist);

2. Has a diameter of more than 2 mm but less than 22 mm;

3. Is accessible to the Spectra-Scope device;

3. Provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Have a known allergy to ethanol;

2. Have a lesion that:

1. Has previously been biopsied, excised or traumatised;

2. Is not intact;

3. Is within 1 cm of the eye;

4. Is on a mucosal surface (lips, genitals);

5. Is on palmar hands;

6. Is on palmar feet;

7. Is on or under nails;

8. Is located on or in an area of visible scarring;

9. Contains foreign matter (tattoo, splinter, marker)

3. Have an active infection;

4. Have an open lesion sampled;

5. Have an autoimmune disease such as lupus or scleroderma vitiligo.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Integrated Specialist Healthcare - Miranda
Recruitment postcode(s) [1] 0 0
2228 - Miranda

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Sung Hyun Pyun

Ethics approval
Ethics application status

Brief summary
The primary objective is to collect emission spectra of normal tissue, pigmented normal
lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the
classifying algorithm.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Saleem Loghdey, M.D.
Address 0 0
Integrated Specialist Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sung Hyun Pyun, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03069846