Skin Cancers - Basal Cell CarcinomaNCT06661577
An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.
An observational study of Skin Cancers - Basal Cell Carcinoma and Skin Cancers - Squamous Cell Carcinoma, run by University of Auckland, New Zealand at 2 sites in New Zealand.
Trial summary
This is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancers - Basal Cell Carcinoma, Skin Cancers - Squamous Cell Carcinoma, Melanoma of Skin
- How many people
- 3,000 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 13 Dec 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The first group of participants (healthy volunteers), will be those who can attend a free skin check at the Clinical Research Centre at the University of Auckland medical school. The second group of participants (patients referred to/attending a clinic for a skin assessment) will be those attending one of five clinics in the city of Auckland and towns of Dargaville and Hokianga, in New Zealand.
Who may be able to join
- 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
Who cannot join
- Tattoo on the skin condition to be measured
- Skin conditions on or directly around the eye area
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Jarrett, MBBS,DCCH,MD contact
New Zealand2 sites
Manukau Super clinic
Auckland, 0604
Paul Jarrett, MBBS, DCCH, DGM,MD, FRCP,FRACP, +6421848109, Paul.Jarrett@middlemore.co.nz
Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial
Auckland, 1140
Michelle B Locke, BHB, MBChB, MD,FRACS(Plastics), +6421963533, Michelle.Locke@middlemore.co.nz
Paul Jarrett, MBBS,DCCH,MD,DGM,MD,FRCP,FRACP, Paul.Jarrett@middlemore.co.nz
About this study
Official 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
This is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. The measurements will provide data which will be used to establish spectral parameters for different skin conditions. Measurements will be benchmarked against diagnoses from medical specialists, and when available confirmed with histological data.
The main question it aims to answer is :
What is the accuracy, in terms of the area under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign skin conditions and skin cancers in adult males and females? Participants include males and females aged ≥18 years who are undergoing assessment of a skin condition (a lesion or rash) by a dermatologist, general practitioner, or plastic surgeon. Participants' attending the clinics will have their skin conditions examined by a clinician. The LumAssure device will then be used to measure Raman spectra of skin conditions and marked by the clinician. The Raman measurements will be benchmarked against skin condition assessment and, where available, diagnosis by a dermatologist, general practitioner, or a plastic surgeon, and for those lesions undergoing biopsy, confirmed with histology data.
Read the detailed description
For this observational study, Raman spectra will be measured in the clinic using the LumAssure device, on patients attending standard of care medical clinics (SOC participants) for skin assessments and/or biopsies, and on healthy volunteers attending a clinical research centre (HV participants). The LumAssure device was developed and utilised in a previous proof of concept study (https://doi.org/10.1016/j.xjidi.2023.100238). Development of a robust classification algorithm capable of distinguishing between malignant vs benign skin conditions requires the collection of clinical measurements from a large and diverse participant population with varied skin Fitzpatrick types.
Participants will be recruited via advertising. All participants must provide informed consent prior to study participation and data collection. SOC participants lesions of interest will be identified for LumAssure measurement by their medical specialist during their clinical visit.
Participant data will be de-identified, utilizing a unique study number, and entered directly into an electronic data capture system.
The study will be conducted in accordance with the protocol and applicable regulatory requirements. Participant rights and safety, and study data integrity will be monitored by an independent contract research organization in accordance with the protocol and established procedures.
Approximately 1,600 - 3,000 skin conditions assessment data point cases required from an estimated 400-750 participants (with an estimated 1-4 lesions per participant) will be collected for this study. The participant sample size has been determined by an independent biostatistician. The Protocol established criteria for data handling, management and analysis in order to achieve the primary and secondary objectives.
- Conditions
- Skin Cancers - Basal Cell Carcinoma, Skin Cancers - Squamous Cell Carcinoma, Melanoma of Skin, Inflammatory Dermatoses, Acral Melanoma, Benign Skin Nevus
- Keywords
- skin cancers, melanoma, diagnostic device
- Medical subject headings
- Carcinoma, Basal Cell, Melanoma, Nevus, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers
The primary endpoint of the study will be the area under the ROC curve (AUCROC) of the LumAssure Raman device measurements for the differentiation between benign skin conditions and skin cancers. The primary aim is to collect sufficient LumAssure Raman device measurements of skin conditions to develop an algorithm which can help detect diagnosed skin conditions and malignancies determined via histological analysis of biopsied samples.
Measured: Day 1, baseline, 12 months
Secondary outcomes (1)
Number of participants with adverse events and descriptions of adverse events
Secondary endpoints:
The number of participants with adverse events will be recorded, and the types of adverse events will be describes and categorized according to severity (high, medium or low risk).
Measured: Day 1, baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start13 Dec 2024 (estimated)
- Primary completion18 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancers - Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Auckland UniServices Ltd., Counties Manukau Health
- Responsible party
- Principal investigator, Michel Nieuwoudt, University of Auckland, New Zealand
- Investigators
- Michel K Nieuwoudt, PhD, Principal investigator, The University of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661577
- Sponsor's protocol ID
- HDEC21297
- Other IDs
- HDEC 21297
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06661577
- Acronym / sponsor ID
- HDEC21297
- Conditions
- Skin Cancers - Basal Cell Carcinoma, Skin Cancers - Squamous Cell Carcinoma, Melanoma of Skin, Inflammatory Dermatoses, Acral Melanoma, Benign Skin Nevus
- Keywords
- skin cancers, melanoma, diagnostic device
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Auckland UniServices Ltd., Counties Manukau Health
- Study start
- 13 Dec 2024 (estimated)
- Primary completion
- 18 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. The measurements will provide data which will be used to establish spectral parameters for different skin conditions. Measurements will be benchmarked against diagnoses from medical specialists, and when available confirmed with histological data.
The main question it aims to answer is :
What is the accuracy, in terms of the area under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign skin conditions and skin cancers in adult males and females? Participants include males and females aged ≥18 years who are undergoing assessment of a skin condition (a lesion or rash) by a dermatologist, general practitioner, or plastic surgeon. Participants' attending the clinics will have their skin conditions examined by a clinician. The LumAssure device will then be used to measure Raman spectra of skin conditions and marked by the clinician. The Raman measurements will be benchmarked against skin condition assessment and, where available, diagnosis by a dermatologist, general practitioner, or a plastic surgeon, and for those lesions undergoing biopsy, confirmed with histology data.
Detailed description
For this observational study, Raman spectra will be measured in the clinic using the LumAssure device, on patients attending standard of care medical clinics (SOC participants) for skin assessments and/or biopsies, and on healthy volunteers attending a clinical research centre (HV participants). The LumAssure device was developed and utilised in a previous proof of concept study (https://doi.org/10.1016/j.xjidi.2023.100238). Development of a robust classification algorithm capable of distinguishing between malignant vs benign skin conditions requires the collection of clinical measurements from a large and diverse participant population with varied skin Fitzpatrick types.
Participants will be recruited via advertising. All participants must provide informed consent prior to study participation and data collection. SOC participants lesions of interest will be identified for LumAssure measurement by their medical specialist during their clinical visit.
Participant data will be de-identified, utilizing a unique study number, and entered directly into an electronic data capture system.
The study will be conducted in accordance with the protocol and applicable regulatory requirements. Participant rights and safety, and study data integrity will be monitored by an independent contract research organization in accordance with the protocol and established procedures.
Approximately 1,600 - 3,000 skin conditions assessment data point cases required from an estimated 400-750 participants (with an estimated 1-4 lesions per participant) will be collected for this study. The participant sample size has been determined by an independent biostatistician. The Protocol established criteria for data handling, management and analysis in order to achieve the primary and secondary objectives.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The first group of participants (healthy volunteers), will be those who can attend a free skin check at the Clinical Research Centre at the University of Auckland medical school. The second group of participants (patients referred to/attending a clinic for a skin assessment) will be those attending one of five clinics in the city of Auckland and towns of Dargaville and Hokianga, in New Zealand.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Tattoo on the skin condition to be measured
- Skin conditions on or directly around the eye area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers
Time frame: Day 1, baseline, 12 months
The primary endpoint of the study will be the area under the ROC curve (AUCROC) of the LumAssure Raman device measurements for the differentiation between benign skin conditions and skin cancers. The primary aim is to collect sufficient LumAssure Raman device measurements of skin conditions to develop an algorithm which can help detect diagnosed skin conditions and malignancies determined via histological analysis of biopsied samples.
1 secondary outcome
Number of participants with adverse events and descriptions of adverse events
Time frame: Day 1, baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Jarrett, MBBS,DCCH,MD contact
Michel K Nieuwoudt, PhD principal investigator
The University of Auckland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancers - Basal Cell Carcinoma and Skin Cancers - Squamous Cell Carcinoma, run by University of Auckland, New Zealand at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel K Nieuwoudt, PhD (+64210378601, m.nieuwoudt@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers (time frame: Day 1, baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.