Skin CancerNCT06463860
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
An observational study of Skin Cancer, run by MetaOptima Technology Inc. at 1 site in United States.
Trial summary
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- DermDx
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 27 Nov 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will be selected from patients with lesions suspected of skin cancer
Who may be able to join
- The subjects must be Primary Care Physicians who are board certified in family medicine or internal medicine.
Who cannot join
- Subjects not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective, Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of Skin Cancers
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.
Read the detailed description
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.
DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer. The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes.
Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output, a single-arm study design has been used.
- Conditions
- Skin Cancer
- Being tested
- DermDx
- Keywords
- Lesions, Artificial Intelligence, Skin Cancer, Malignant Lesions, Benign Lesions
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermDxDevice
DermDx is a computer-aided diagnosis (CADx) software product that uses an AI-based algorithm to evaluate non-invasively captured images of skin lesions obtained from any commercially available dermoscopes. DermDx uses state-of-the-art deep neural network models that have been trained on a large database of dermoscopy images. DermDx analyzes the image of a new skin lesion and provides an output.
| Study group | Role | What they receive |
|---|---|---|
| Double reading of all cases with and without software output | Double reading of all cases with and without software output Receives: Device: DermDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the diagnostic sensitivity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
The change in the diagnostic sensitivity of the PCPs with the use of DermDx results than without the use of DermDx results in the diagnosis of lesions suspicious of skin cancer, in comparison to the ground truth.
Measured: 6 months
The change in the diagnostic accuracy of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
The change in the Area Under the Curve for the diagnosis of skin cancer lesions by PCPs with the use of DermDx results than without the use of DermDx results, in comparison to the ground truth.
Measured: 6 months
Secondary outcomes (4)
The change in sensitivity of management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer.
The change in the sensitivity of the disease management decision of the PCPs with the use of DermDx results than without the use of DermDx results in the management of lesions suspicious of skin cancer, in comparison to the ground truth.
Measured: 6 months
The accuracy of the disease management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer.
The change in the Area Under the Curve (AUC) for the disease management decision of the PCPs with the use of DermDx results than without the use of DermDx results for lesions suspicious of skin cancer, in comparison to the ground truth.
Measured: 6 months
Diagnostic specificity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
The diagnostic specificity of the PCPs with the use of DermDx results and without the use of DermDx results in the diagnosis of lesions suspicious of skin cancer, in comparison to the ground truth.
Measured: 6 months
The specificity of the disease management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer.
The specificity of the disease management decision of the PCPs with the use of DermDx results and without the use of DermDx results in the management of lesions suspicious of skin cancer, in comparison to the ground truth.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start12 Jun 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetaOptima Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Majid Razmara, PhD, Study chair, MetaOptima Technology Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463860
- Sponsor's protocol ID
- Real-Dx
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. Cases will be assigned with a unique case identifier, which will be visible on each image and clinical information pertaining to the case, for tracking purposes.
Publications
Katragadda C, Finnane A, Soyer HP, Marghoob AA, Halpern A, Malvehy J, Kittler H, Hofmann-Wellenhof R, Da Silva D, Abraham I, Curiel-Lewandrowski C; International Society of Digital Imaging of the Skin (ISDIS)-International Skin Imaging Collaboration (ISIC) Group. Technique Standards for Skin Lesion Imaging: A Delphi Consensus Statement. JAMA Dermatol. 2017 Feb 1;153(2):207-213. doi: 10.1001/jamadermatol.2016.3949.
PubMed 27892996Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19.
PubMed 20231499Armstrong BK, Kricker A. The epidemiology of UV induced skin cancer. J Photochem Photobiol B. 2001 Oct;63(1-3):8-18. doi: 10.1016/s1011-1344(01)00198-1.
PubMed 11684447Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.
PubMed 22251204Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
PubMed 31896400US Department of Health and Human Services. The Surgeon General's Call to Action to Prevent Skin Cancer. Washington (DC): Office of the Surgeon General (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK247172/
PubMed 25320835Carlson JA. Tumor doubling time of cutaneous melanoma and its metastasis. Am J Dermatopathol. 2003 Aug;25(4):291-9. doi: 10.1097/00000372-200308000-00003.
PubMed 12876486Hajdarevic S, Hornsten A, Sundbom E, Isaksson U, Schmitt-Egenolf M. Health-care delay in malignant melanoma: various pathways to diagnosis and treatment. Dermatol Res Pract. 2014;2014:294287. doi: 10.1155/2014/294287. Epub 2014 Jan 5.
PubMed 24516469Roetzheim RG, Lee JH, Ferrante JM, Gonzalez EC, Chen R, Fisher KJ, Love-Jackson K, McCarthy EP. The influence of dermatologist and primary care physician visits on melanoma outcomes among Medicare beneficiaries. J Am Board Fam Med. 2013 Nov-Dec;26(6):637-47. doi: 10.3122/jabfm.2013.06.130042.
PubMed 24204060Ehrlich A, Kostecki J, Olkaba H. Trends in dermatology practices and the implications for the workforce. J Am Acad Dermatol. 2017 Oct;77(4):746-752. doi: 10.1016/j.jaad.2017.06.030. Epub 2017 Aug 4.
PubMed 28784330Feng H, Berk-Krauss J, Feng PW, Stein JA. Comparison of Dermatologist Density Between Urban and Rural Counties in the United States. JAMA Dermatol. 2018 Nov 1;154(11):1265-1271. doi: 10.1001/jamadermatol.2018.3022.
PubMed 30193349Glazer AM, Farberg AS, Winkelmann RR, Rigel DS. Analysis of Trends in Geographic Distribution and Density of US Dermatologists. JAMA Dermatol. 2017 Apr 1;153(4):322-325. doi: 10.1001/jamadermatol.2016.5411. No abstract available.
PubMed 28146246Tschandl P, Codella N, Akay BN, Argenziano G, Braun RP, Cabo H, Gutman D, Halpern A, Helba B, Hofmann-Wellenhof R, Lallas A, Lapins J, Longo C, Malvehy J, Marchetti MA, Marghoob A, Menzies S, Oakley A, Paoli J, Puig S, Rinner C, Rosendahl C, Scope A, Sinz C, Soyer HP, Thomas L, Zalaudek I, Kittler H. Comparison of the accuracy of human readers versus machine-learning algorithms for pigmented skin lesion classification: an open, web-based, international, diagnostic study. Lancet Oncol. 2019 Jul;20(7):938-947. doi: 10.1016/S1470-2045(19)30333-X. Epub 2019 Jun 12.
PubMed 31201137Menzies SW, Sinz C, Menzies M, Lo SN, Yolland W, Lingohr J, Razmara M, Tschandl P, Guitera P, Scolyer RA, Boltz F, Borik-Heil L, Herbert Chan H, Chromy D, Coker DJ, Collgros H, Eghtedari M, Corral Forteza M, Forward E, Gallo B, Geisler S, Gibson M, Hampel A, Ho G, Junez L, Kienzl P, Martin A, Moloney FJ, Regio Pereira A, Ressler JM, Richter S, Silic K, Silly T, Skoll M, Tittes J, Weber P, Weninger W, Weiss D, Woo-Sampson P, Zilberg C, Kittler H. Comparison of humans versus mobile phone-powered artificial intelligence for the diagnosis and management of pigmented skin cancer in secondary care: a multicentre, prospective, diagnostic, clinical trial. Lancet Digit Health. 2023 Oct;5(10):e679-e691. doi: 10.1016/S2589-7500(23)00130-9.
PubMed 37775188Madeja J, Kelsberg G, Safranek S. Does screening by primary care providers effectively detect melanoma and other skin cancers? J Fam Pract. 2020 Mar;69(2):E10-E12. No abstract available.
PubMed 32182298
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of Skin Cancers
- ClinicalTrials.gov ID
- NCT06463860
- Acronym / sponsor ID
- Real-Dx
- Conditions
- Skin Cancer
- Keywords
- Lesions, Artificial Intelligence, Skin Cancer, Malignant Lesions, Benign Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- MetaOptima Technology Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 18 Jun 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 proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.
Detailed description
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.
DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer. The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes.
Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output, a single-arm study design has been used.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double reading of all cases with and without software output | – | Device: DermDxDouble reading of all cases with and without software output |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected from patients with lesions suspected of skin cancer
Key inclusion criteria (1 listed)
- The subjects must be Primary Care Physicians who are board certified in family medicine or internal medicine.
Key exclusion criteria (1 listed)
- Subjects not meeting inclusion criteria.
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 |
|---|---|---|
| DermDxDermDx is a computer-aided diagnosis (CADx) software product that uses an AI-based algorithm to evaluate non-invasively captured images of skin lesions obtained from any commercially available dermoscopes. DermDx uses state-of-the-art deep neural network models that have been trained on a large database of dermoscopy images. DermDx analyzes the image of a new skin lesion and provides an output. | Device | Double reading of all cases with and without software output |
Primary outcome
The change in the diagnostic sensitivity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
Time frame: 6 months
The change in the diagnostic sensitivity of the PCPs with the use of DermDx results than without the use of DermDx results in the diagnosis of lesions suspicious of skin cancer, in comparison to the ground truth.
The change in the diagnostic accuracy of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
Time frame: 6 months
The change in the Area Under the Curve for the diagnosis of skin cancer lesions by PCPs with the use of DermDx results than without the use of DermDx results, in comparison to the ground truth.
4 secondary outcomes
The change in sensitivity of management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer.
Time frame: 6 months
The accuracy of the disease management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer.
Time frame: 6 months
Diagnostic specificity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
Time frame: 6 months
The specificity of the disease management decision of the Primary Care Physicians (PCPs) with and without the use of DermDx in the management of lesions suspicious of skin cancer.
Time frame: 6 months
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 19 Dec 2024.
- Background: PubMed 27892996Katragadda C, Finnane A, Soyer HP, Marghoob AA, Halpern A, Malvehy J, Kittler H, Hofmann-Wellenhof R, Da Silva D, Abraham I, Curiel-Lewandrowski C; International Society of Digital Imaging of the Skin (ISDIS)-International Skin Imaging Collaboration (ISIC) Group. Technique Standards for Skin Lesion Imaging: A Delphi Consensus Statement. JAMA Dermatol. 2017 Feb 1;153(2):207-213. doi: 10.1001/jamadermatol.2016.3949.
- Background: PubMed 20231499Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19.
- Background: PubMed 11684447Armstrong BK, Kricker A. The epidemiology of UV induced skin cancer. J Photochem Photobiol B. 2001 Oct;63(1-3):8-18. doi: 10.1016/s1011-1344(01)00198-1.
- Background: PubMed 22251204Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.
- Background: PubMed 31896400Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
- Background: PubMed 25320835US Department of Health and Human Services. The Surgeon General's Call to Action to Prevent Skin Cancer. Washington (DC): Office of the Surgeon General (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK247172/
- Background: PubMed 12876486Carlson JA. Tumor doubling time of cutaneous melanoma and its metastasis. Am J Dermatopathol. 2003 Aug;25(4):291-9. doi: 10.1097/00000372-200308000-00003.
- Background: PubMed 24516469Hajdarevic S, Hornsten A, Sundbom E, Isaksson U, Schmitt-Egenolf M. Health-care delay in malignant melanoma: various pathways to diagnosis and treatment. Dermatol Res Pract. 2014;2014:294287. doi: 10.1155/2014/294287. Epub 2014 Jan 5.
- Background: PubMed 24204060Roetzheim RG, Lee JH, Ferrante JM, Gonzalez EC, Chen R, Fisher KJ, Love-Jackson K, McCarthy EP. The influence of dermatologist and primary care physician visits on melanoma outcomes among Medicare beneficiaries. J Am Board Fam Med. 2013 Nov-Dec;26(6):637-47. doi: 10.3122/jabfm.2013.06.130042.
- Background: PubMed 28784330Ehrlich A, Kostecki J, Olkaba H. Trends in dermatology practices and the implications for the workforce. J Am Acad Dermatol. 2017 Oct;77(4):746-752. doi: 10.1016/j.jaad.2017.06.030. Epub 2017 Aug 4.
- Background: PubMed 30193349Feng H, Berk-Krauss J, Feng PW, Stein JA. Comparison of Dermatologist Density Between Urban and Rural Counties in the United States. JAMA Dermatol. 2018 Nov 1;154(11):1265-1271. doi: 10.1001/jamadermatol.2018.3022.
- Background: PubMed 28146246Glazer AM, Farberg AS, Winkelmann RR, Rigel DS. Analysis of Trends in Geographic Distribution and Density of US Dermatologists. JAMA Dermatol. 2017 Apr 1;153(4):322-325. doi: 10.1001/jamadermatol.2016.5411. No abstract available.
- Individual participant dataSharing planned: No. The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. Cases will be assigned with a unique case identifier, which will be visible on each image and clinical information pertaining to the case, for tracking purposes.
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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.
Majid Razmara, PhD study chair
MetaOptima Technology Inc.
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 MetaOptima Technology 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 1 inclusion and 1 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 19 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?
The change in the diagnostic sensitivity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT06463860, which also lists 17 linked publications.
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 19 Dec 2024.