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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03069846




Registration number
NCT03069846
Ethics application status
Date submitted
20/02/2017
Date registered
3/03/2017
Date last updated
20/04/2018

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
Speclipse-2016-10
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
Kidney
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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

Outcomes
Primary outcome [1] 0 0
The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin.
Timepoint [1] 0 0
We plan to recruit 150 patients within a 3 month time frame.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Diagnosis
Allocation to intervention
N/A
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/06/2018
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
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
Name
Sung Hyun Pyun
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT03069846
Trial related presentations / publications
Public notes

Contacts
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
82-10-2227-4723
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03069846