Skin CancerDERM-SUCCESSNCT06690086
DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
An observational study of Skin Cancer, run by DermaSensor, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Lesion biopsy and DermaSensor Device Use
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,028 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 9 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men or women of any ethnic group aged 22 and older with at least one skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy.
Who may be able to join
- Men or women of any ethnic group aged 22 and older
- Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
- Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)
Who cannot join
- Lesion < 2.5mm in diameter or > 15mm in diameter
- Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
- Lesion on area of crust, psoriasis, eczema or similar skin condition
- Lesion has erosion and/or ulceration with no area >2.5mm intact
- Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
- Lesion in which the device tip cannot be placed entirely within the border of the targeted area
Show all 13Show fewer
- Lesion located on acral skin (e.g. sole or palms)
- Lesion located within 1 cm of the eye
- Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
- Lesion located on mucosal surfaces (e.g. genitals, lips)
- Lesion located on acute sunburn
- Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy
- Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)
The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.
Read the detailed description
A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.
- Conditions
- Skin Cancer
- Being tested
- Lesion biopsy, DermaSensor Device Use
- Keywords
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Elastic Scattering Spectroscopy
- Medical subject headings
- Skin Neoplasms, Melanoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesion biopsyProcedure or surgery
Lesions enrolled in the study are biopsied to confirm histopathology
DermaSensor Device UseDevice
Users are blinded to the DermaSensor Device result
| Study group | Role | What they receive |
|---|---|---|
| Subjects with skin lesions suggestive of skin cancer | Subjects with primary skin lesion(s) suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess the DermaSensor device accuracy in determining risk of malignancy. Receives: Procedure: Lesion biopsy; Device: DermaSensor Device Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
Measured: Day 1
Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
Measured: Day 1
Secondary outcomes (1)
Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start17 Aug 2020
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermaSensor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Stephen P Merry, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690086
- Sponsor's protocol ID
- CSP-18-0002
- Acronym
- DERM-SUCCESS
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)
- ClinicalTrials.gov ID
- NCT06690086
- Acronym / sponsor ID
- DERM-SUCCESS / CSP-18-0002
- Conditions
- Skin Cancer
- Keywords
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Elastic Scattering Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- DermaSensor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 15 Nov 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.
The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.
Detailed description
A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with skin lesions suggestive of skin cancer | – | Procedure: Lesion biopsy, Device: DermaSensor Device UseSubjects with primary skin lesion(s) suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess the DermaSensor device accuracy in determining risk of malignancy. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men or women of any ethnic group aged 22 and older with at least one skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy.
Key inclusion criteria (3 listed)
- Men or women of any ethnic group aged 22 and older
- Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
- Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)
Key exclusion criteria (13 listed)
- Lesion < 2.5mm in diameter or > 15mm in diameter
- Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
- Lesion on area of crust, psoriasis, eczema or similar skin condition
- Lesion has erosion and/or ulceration with no area >2.5mm intact
- Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lesion biopsyLesions enrolled in the study are biopsied to confirm histopathology | Procedure or surgery | Subjects with skin lesions suggestive of skin cancer |
| DermaSensor Device UseUsers are blinded to the DermaSensor Device result | Device | Subjects with skin lesions suggestive of skin cancer |
Primary outcome
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
Time frame: Day 1
Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
Time frame: Day 1
1 secondary outcome
Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stephen P Merry, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by DermaSensor, Inc. at 1 site in United States.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC (time frame: Day 1). The study lists 2 primary outcomes in all. 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 9 Dec 2024.