Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Melanoma

Pigmentation Disorders

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

* fPAM imaging will be performed prior to scheduled excision. The time to excision will not be extended longer than 2 weeks for imaging purposes.
* When the participant presents for imaging, the area of the thickest lesion depth will be determined by fPAM. The area of deepest thickness will be marked perpendicular to the longest axis of the lesions and a clinical photo will be taken and placed in the image storage database.
* Surgical excision will be performed as standard of care and fPAM depth will be compared with histological examination.
* To image CTCs in cutaneous blood vessels, a small cuticle area on a finger will be imaged (Single cell PAM imaging) and the most distal cutaneous metastasis or metastasis of largest diameter will be imaged

-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.

Functional photoacoustic microscopy

Standard of care surgical excision

Single cell photoacoustic microscopy

Lynn Cornelius, M.D.

The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.

In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.

fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

Pilot Study to Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

-The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.

Washington University School of Medicine

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Method for noninvasive detection of cutaneous malignancies

The device collects two types of tissue spectra: i) laser-induced fluorescence spectra and ii) white light reflectance spectra. This portable reflectance spectrofluorimeter collects spectra in a fraction of a second. Light collection and delivery are achieved via an optical fiber probe. The optical fiber probe is approximately 1 mm in diameter and 3 m long. The same probe collects light emitted from the tissue and delivers it back to the instrument for spectral analysis.

Spectral Diagnosis Probe

Michael Migden, MD

The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.

The spectral-diagnosis probe being used in this study uses dim pulses of light to identify features of tissue that may be related to the status of skin cancer. The probe is shaped like a catheter, and it has a camera on the end, which takes pictures of the skin.

If you agree to take part in this study, you will be asked questions about your age, race, smoking status, and the status of any diseases you may have (such as diabetes, connective tissue disease, and infectious disease). It should take about 5 minutes to answer these questions.

The study doctor will then decide which of your lesions are suitable for imaging by the probe. If necessary, any hair on or around the lesion(s) will be shaved or trimmed. The area(s) of skin being imaged will be cleaned with rubbing alcohol.

As part of your exam, the study doctor will use the probe to measure the selected areas of tissue. To perform the spectral-diagnosis measurement, the probe will be gently placed on the surface of your skin. Each selected area of your skin will take about a few seconds to image. The probe will shine different types of light onto the skin, and it will collect the light that reflects from the skin surface. The light signals will be stored so that researchers can look at them. Preparing the lesion, imaging it, and collecting the light signals should take about 10-15 minutes per lesion.

After all of the imaging is over, you will have biopsies performed on the lesions that your study doctor has decided are in need of such treatment as part of your standard care.

After this clinic visit, your participation in the study will be over.

This is an investigational study. The imaging probe is not commercially available or FDA approved. At this time, it is being used in research only. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.

Spectral Diagnosis of Cutaneous Malignancy

University of Texas at Austin

M.D. Anderson Cancer Center

DermLoop Learn is our AI augmented digital educational platform with case training on a library of 18,000+ benign and malignant skin lesion as well as written learning modules for the most common skin lesion diagnosis.

DermLoop Learn

Louisa Bønløkke Hansen

Background:

Melanoma mortality remains almost stable with a 0.2-1.5% increase annually despite rapid growth in reported melanoma incidence of 2.5-8.6% per year. Part of this discrepancy could be explained by overdiagnosis of melanoma, which may be as high as 54%. Histopathology is considered the gold standard diagnosis for melanocytic lesions despite only a moderately good intra- and inter-rater reliability. A possible explanation of why the inter-rater reliability is suboptimal could be that pathologists are inexperienced, extra cautious, or lack sufficient information needed for a reliable diagnosis.It has been hypothesized that the horizontal overview of a lesion through dermoscopy combined with clinical information on a given tumor, enables the generation of a tentative diagnosis that the pathologists can use to actively search for signs of pathology. Former research shows that clinicians' competence in dermoscopy can be improved by a short learning intervention, but that these skills aren't sustainable

Aim:

The aim of this study is to examine how acquired basic skills in dermoscopy of pigmented lesions and access to clinical images of a lesion, affect pathologists' confidence, accuracy and inter-rater reliability when interpreting melanocytic lesions.

Method:

Preparative phase:

Case database

Lesion data will be collected from patients during the period between 02.11.2020 and 22.01.2021 at the Department of Plastic Surgery, Herlev Hospital. Requirements for eligibility are:

The patient is referred through the clinical cancer pathways for melanoma The lesion is excised upon evaluation by the plastic surgeon.

An internal investigation has shown that approximately ⅓ of all melanocytic lesions referred in the clinical cancer pathway are melanomas (in situ and invasive).

Patients will receive oral and written information about the project and be asked to sign a consent form before participation. Participation will not affect the treatment, diagnostics, or follow-up of included patients. Upon consent the following information will be collected for each lesion:

Clinical image Dermoscopic image Patients´ CPR-number (personal ID-number) Gender and age of the patient Location of skin tumor (3D avatar) Medical history (congenital nevi, pregnant patient, how long has it been present, appearance change, symptoms, former melanoma, family history of melanoma, sun exposure within the last six months) As soon as the lesions have been prepared for pathological examination, a representative slide (including pathognomic features) for each skin lesion will be chosen by an experienced dermatopathologist. This slide will subsequently be digitized and coupled to the remaining information (dermoscopic and clinical image, tumor location, gender, age, lesion information, etc.). Thereafter the CPR number is deleted, rendering the case anonymous. Each case will be stored in a database under a random anonymous ID number.

Web-based IT-platform

In order to maximize patient participation and the number of pathologists that can be included in the study, the investigators will develop an IT platform for the trial. The platform will enable the following features:

Sign-in Automated randomization Login Case presentation Diagnosis of cases Tracking

The IT platform:

The diagnostic options will be based on the standardized MPATH-Dx formula (participants will be introduced to this before participation) used in former studies on inter-rater reliability. Subsequent to diagnosing the lesion, participating pathologists will rate their confidence in the chosen diagnosis on a 5-step Likert scale. Participants will be grouped by department or affiliation center in order to enable post-hoc cluster analyses and continuous status reports during the study. The tracking feature will enable search pattern analysis including time per diagnosis and percentage of time spent looking at the histology slide and dermoscopy photo. Saliency heat maps will be developed that enable visualization of "classical" search patterns (both global and feature specific) in both study groups.

Executive phase:

General pathologists and dermatopathologists from Denmark, Australia and other countries will be enrolled between 1.09.2021 and 1.10.2021. All participants will be sent an email informing them about the trial and the handling of their data before signing a digital consent. Upon inclusion each enrolled pathologist will be asked to fill out a digital sign-in form with the following variables:

Name E-mail address (including verification) Age Gender Subspecialization (general pathologist or dermatopathologist) Number of years interpreting skin lesions Caseload from melanocytic lesions per month Percentage of caseload from melanocytic lesions Number of second opinion assessments per month Number of second opinion referrals per month Former training in dermoscopy (yes/no) Perceived relevance of dermoscopic images during histopathological evaluation on a 5-step Likert scale

Following the sign-in, all participants will be asked to answer a dermoscopy test consisting of 20 formerly validated test items. Then they will be automatically stratified by level of dermatopathological experience and randomized (allocation ratio 1:1) to either the intervention or control group. Participants in the intervention group will receive immediate access to a previously developed digital (tablet or smartphone) educational platform in dermoscopy of melanocytic lesions and then answer the dermoscopy test again, before diagnosing the lesions in this study. Participants in the control group will not be given access to the learning intervention but will diagnose the lesions from this study immediately after sign up and dermoscopy test. Each participant will be asked to assess a minimum of 50 cases within 14 days, preferably all 200 cases.

Statistics:

The accuracy will be measured as the number of correct answers divided by the total number of answers. Consensus agreement among pathologists with a caseload of more than 60 melanocytic lesions per month and at least 10 years of experience will be used as the gold standard. Inter-rater reliability will be measured using generalizability theory that allows calculations in nested and unbalanced designs. Mean time spent per diagnosis and diagnostic confidence during 1st evaluation will be compared between the study groups using independent t-tests. A post hoc ANOVA will compare time spent per diagnosis and confidence of pathologists grouped by time spent training in dermoscopy.

Randomized clinical trial. Pathologists are randomized to either the control group or det intervention, allocation ratio 1:1.

Participating Pathologists are either given access to a learning intervention called DermLoop Learn for a short period, or not given access to any learning intervention. During the trial, both groups are interpreting histopathological skin lesions with acces to clinical information, an overview picture, and a dermoscopic picture of the lesion.

Dermoscopy Augmented Histology Trial

Correlation Between Dermoscopy Training of Pathologists and Improvement of Histopathological Interpretation of Skin Lesions

Comparison of the pathologists interpretation/diagnosis of each case.

Comparing time spent per case (overall) and time spent on each image (clinical, dermoscopic, histopathological) with the interpretation of the case e.g. the diagnosis.

Herlev Hospital

Medical student

The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.

Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device

SECM Skin Imaging

Guillermo Tearney, M.D, PhD.

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

The quality, resolution and depth of the images will be reviewed by the PI. This is a qualitative analysis to determine the feasibility of the device, the parameters mentioned will be compared to correlative data obtained from the dermatoscope control. Unit measurements are not available.

Massachusetts General Hospital

Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Lisbet Rosenkrantz Hôlmich, MD. prof.

It has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images. The primary outcome of the upcoming DAHT RCT (Dermoscopy Augmented Histology Trial, a randomized controlled trial) is the diagnostic value (accuracy, sensitivity, and specificity) for the intervention and control group. For this purpose, we need an irrefutable gold standard diagnosis for all DAHT cases. The DAHT consensus trial strives to establish this gold standard through a four-phased Delphi-like process.

Aim: To establish a gold-standard diagnosis for all DAHT cases.

Data collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021

DAHT platform: Made in 2021-2023 by Melatech

Consensus agreement: Four dermatopathologists assess all DAHT cases, year 2023

Background

Several publications suggest that the increasing melanoma incidence may partly be caused by histopathological overdiagnosis. Pathologists provide the current gold standard in skin lesion diagnostics, most often primarily based on the interpretation of histological slides. Still, it has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. However, it can be challenging to interpret clinical and dermoscopic images, and mastery typically requires more than six years of clinical experience. This learning journey can be significantly shortened if the trainee receives comprehensive training in pattern recognition for dermoscopy and clinical images, including immediate, accurate, and individualized feedback and access to a library with a large selection of skin lesion cases. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images.

Former studies have only focused on melanocytic lesions. Still, most pathologists will receive both melanocytic and pigmented non-melanocytic lesions (seborrheic keratoses, dermatofibromas, etc.) due to clinical suspicion of melanoma. This study includes an un-filtered selection of 211 clinically melanoma-suspect skin lesions excised at a specialized surgical department; this material is named the DAHT cases.

The primary outcome of the upcoming DAHT RCT (Dermoscopy Augmented Histology Trial, a randomized controlled trial) is the diagnostic value (accuracy, sensitivity, and specificity) for the intervention and control group. For this purpose, we need an irrefutable gold standard diagnosis for all DAHT cases. The DAHT consensus trial strives to establish this gold standard through a four-phased Delphi-like process.

Aim: To establish a gold-standard diagnosis for all DAHT cases.

Method

Case Database:

Lesion data were collected from patients between 02.11.2020 and 22.01.2021 at the Department of Plastic Surgery, Herlev Hospital. Requirements for eligibility for the current study are:

The patient was referred through the clinical cancer pathways for melanoma. The lesion was excised upon evaluation by the plastic surgeon.

Patients received oral and written information about the project and were asked to sign a consent form before participation. The participation did not affect the included patients' treatment, diagnostics, or follow-up. Upon consent, the following information was collected for each lesion:

Clinical image Dermoscopic image Patients´ CPR-number (personal ID-number) Sex and age of the patient Location of skin tumor (on a 3D avatar) Medical history (former treatment, congenital nevi, if pregnant, time of appearance of skin lesion, change in appearance, symptoms, former melanoma or other skin diseases, family history of melanoma, sun exposure within the last six months) After excision, the specimen was prepared for pathological examination and a representative hematoxylin-eosin stain and, if available, a MelanA stain for each skin lesion was chosen for the study by an experienced dermatopathologist. These stains were subsequently digitized and coupled with the relevant information (dermoscopic and clinical image, tumor location, sex, age, lesion information, etc.). The CPR number was deleted, rendering the case anonymous. Each case is stored in a database under a random anonymous ID number.

Web-based IT platform

To make it easy for pathologists to participate, the investigators have developed an IT platform for the trial (The DAHT platform). The platform enables the following features:

Sign-in Automated randomization Login Case presentation Diagnosis of cases and subquestions Tracking

The diagnostic options will be based on the standardized MPATH-Dx version 2.0 with additional non-melanocytic options based on the most common diagnoses to be excised due to suspicion of malignancy. After diagnosing the lesion, participating pathologists will rate their confidence and difficulty in the chosen diagnosis on a 6-step Likert scale similar to the one used in the MPATH-Dx system. They will also be asked whether they want a second opinion, if they need additional stains or tests, and which tests/stains. All cases will be presented in a randomized order unique to each participant.

Consensus agreement The consensus agreement on the diagnosis of each case will be reached through a Delphi-like process consisting of four phases.

Phase 1 - Independent diagnostics All participating experts will be asked to independently review and diagnose all 211 DAHT cases. This will be facilitated through the DAHT platform (developed for the purpose), and the primary investigator will send regular reminders if needed. The website continuously saves the experts' progress, ensuring they can diagnose the 211 cases in small batches over 30 days. All experts will be asked to take notes regarding suggestions to improve the DAHT platform and DAHT dataset.

Phase 2 - Online discussion When phase 1 has been concluded, all experts will be invited to an online discussion. Issues and suggestions regarding the DAHT cases and platform will be discussed during the meeting. The primary investigator will formulate a plan to remedy/accommodate these. If the expert group concludes that additional cases are required for the DAHT study, these will be collected by the primary investigator.

Phase 3 - Review of ambiguous cases An anonymous report with data from Phase 1 and a list of all ambiguous cases with less than 80% observer agreement will be emailed to the participating experts. The experts will be asked to reevaluate the ambiguous cases independently, with the data from phase 1 at hand. Similar to the previous phase, cases with less than 80% observer agreement will go on to phase 4.

Phase 4 - Consensus discussion (online or physical) The primary investigator will facilitate a consensus agreement discussion among the experts regarding the most challenging cases where a disagreement persists beyond Phase 3. An anonymous report on data from Phase 3 will be available during this meeting.

Four international well-acknowledged experts in dermatopathology have been invited to participate as the expert panel in this study.

Dermoscopy Augmented Histology Trial, Consensus Agreement Diagnosis Made by Dermatopathology Experts

Diagnostic Agreement Among Expert Dermatopathologists on Skin Lesions Clinically Suspicious of Melanoma

Diagnostic agreement among participating experts in all DAHT cases with individual assessments and, later on, a discussion about ambiguous cases.

Medical doctor

Melanosis

Hyperpigmentation

Confocal imaging of the conjunctival lesion

HRT III with Non-Contact Cornea Rostock Module

Pedram Hamrah, MD

Carol Shields, MD

Arman Mashayekhi, MD

Bita Esmaeli, MA, MD

This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to evaluate the use of in vivo confocal microscopy in evaluation of response to treatment. The modified technique with Heidelberg Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in vivo as preliminary studies have shown.

Conjunctival melanoma is a potentially lethal neoplasm, with an average 10-year mortality rate of 30%, and 15-year mortality rate of 45%. This condition occurs mainly in the white population, with rare reports in black and other non-white populations. Recent studies have indicated that like cutaneous melanoma, the incidence of conjunctival melanoma is increasing.

Conjunctival Malignant Melanoma (MM) is also currently diagnosed based upon clinical grounds, through observation of the growth of the suspected lesions over regular intervals of time. Unfortunately simple slit lamp examination is currently the only clinical diagnostic visual instrument available in medical practice, and the early diagnosis of MM by slit-lamp examination is still rather poor. Further the diagnosis of invasive conjunctival MM is currently established by conjunctival excisional biopsy and defined by the invasion of the underlying substantia propria of the conjunctiva by atypical tumor cells, especially when there is loss of the maturation. Regarding the management of malignant melanoma, unfortunately the extensive horizontal and even vertical growth of this neoplasm does not always lend itself to simple excision leading to exenteration. As a vision-sparing alternative, local excision with cryotherapy has become the treatment of choice. Long-term follow-up has shown that local recurrences are common. More recently, topical chemotherapy with mitomycin C (MMC) has been used to treat cases with extensive PAM with atypia , because the pigmented margin is used as a guide for most conservative treatments, the tumor's edge may be missed.

Recurrent conjunctival MM often presents as an amelanotic mass and may be mistaken for pyogenic granuloma in a patient who has had multiple previous excisions of conjunctival MM, even though the original tumor may have been pigmented. Because of the lack of pigment, these tumors can remain unrecognized and progressively enlarge, especially if the patient has had previous surgery and conjunctival scarring. In addition, the tumor margins of recurrent amelanotic conjunctival MM may be indistinct. These factors can lead to delayed recognition and the unnecessary need for exenteration. Despite these radical procedures, which usually lead to loss of vision or the eye, these patients have been shown to have a poor survival rate, suggesting that metastasis has already occurred at the time of treatment. This confirms that the extent of the disease at diagnosis is the most important factor to determine the outcome. Recurrence of conjunctival MM is reported at 26% at 5 years and, 51% at 10 years.

MM of the conjunctival represents one of the greatest challenges in early or preventive detection. Whereas surgical excision in early stages of tumor development is almost always curative, delayed recognition puts the patient at risk of destructive growth and death once the tumor has progressed to competence for metastasis. Accurate diagnosis of pigmented lesions of the conjunctiva such as nevi, primary, and secondary acquired melanosis and MM present a challenge to both the ophthalmologist and the pathologist. It is not possible clinically to distinguish between PAM with and without atypia. The ability to detect early MM remains of paramount importance in our efforts to curtail deaths related to this malignancy. The implementation and utilization of in vivo imaging technologies in clinical practice would enhance our ability to detect MM while this cancer is in its early stages and curable. Further, accurate assessment of therapeutic tumor response is critical for evaluation of chemotherapy results in patients, and in clinical trials. Tumor response is also a guide for the clinician and patient or study. Early, accurate prediction of non-response would allow an early change to second-line treatment, thus sparing patient's unnecessary toxicity, psychological morbidity and delay of initiation of effective treatment. These are very few variables that investigators, as clinicians, can control regarding the management of conjunctival MM. However, early detection, technique and time of surgery may ultimate after tumor recurrence, need for orbital exenteration, tumor metastasis, and patient death. This non-invasive imaging technique that is now available for clinical studies might help in early detecting and preventing above mentioned problems.

In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions

Study data was not analyzed due to sample size and no statistical power.

Heidelberg Retina Tomography (HRT) and Optical Coherence Tomography (OCT) will be used to measure pigmented conjunctival lesions. (HRT) is performed with a confocal scanning laser ophthalmoscope. Along with corneal analysis software, the HRT is able to image cells and cell layers within the cornea. Optical Coherence Tomography (OCT) is a noninvasive optical imaging modality analogous to an ultrasound B-scan. OCT images will be used to estimate tumor depth.

Immunohistochemistry results will be recorded from stained tissue samples obtained during surgical resections scheduled for study subjects with newly diagnosed conjunctival lesions. These patients will have HRT and OCT imaging performed prior to their standard of care surgery to remove the conjunctival lesion. Histologic and immunohistochemistry results and clinicopathologic findings will be analyzed by two observers and correlated with IVCM and OCT images of the same lesions.

Wills Eye

Massachusetts Eye and Ear Infirmary

Group A is composed of expert dermatologists. Group A doctors will have at their disposal 150 dermoscopic photos, x20 dermatoscopic photos according to the usual practice of pigmented genital tumors.

The dermatologists will characterize the dermatoscopy with a standardized reading grid to assess the different dermatoscopic patterns of genital tumors.

Group B is composed of gynecologists (Group B1) and general practitioners (B2) Group B physicians will only perform dermatoscopy x 400. They will have been given a maximum of 1 hour's training to identify melanosis-type pigmented tumors, which are the most frequent benign tumors in x 400 dermatoscopy.

Only three x400 dermatoscopy patterns will be presented to them to the exclusion of all others, which are sufficient to identify benign lesions.

Artificial intelligence: the skin Artificial intelligence software, a learning base will be provided, different from the evaluation base and the test base.

Analysis of photos of pigmented tumours by the three groups with different techniques for each group to compare them.

Analysis of photos of pigmented tumours by the three groups

Jean Luc Perrot, MD PhD

Pigmented lesions of the genital mucosa are common, affecting between 10% and 20% of the population. The clinical appearance is sometimes confusing. They are often extensive, irregular, and inhomogeneous in color, which can make them look suspicious. Moreover, dermatoscopic imaging is often complex to interpret, as shown by the many different patterns reported in the literature.

Thus, preliminary work in confocal microscopy has shown that it is possible to simplify diagnosis by using microscopic, in vivo, non-invasive imaging. However, CIM cameras are rare, very expensive and difficult to access.

Conversely, digital dermatoscopes with 400x magnification are much less expensive and can also allow, in a certain number of cases, an examination at the cellular level of tumors, with, in our opinion, the advantage of being easy to learn. In the context of the pooling of resources within medical centers in particular, their dissemination should accelerate. Furthermore, x400 dermatoscopy can provide similar information to IVCM for the most frequent black genital tumors.

The hypothesis that motivates this work is that X400 dermatoscopy in the hands of non-experts would allow a fast increase in their diagnostic capacity by identifying the main genital pigmented tumor, namely melanosis, and thus improve the use of expert centers relieved of the care of benign tumors.

Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20

Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists (3 Gynecologists, 3 General Practitioners) and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20 Interpreted by 3 Expert Dermatologists, for the Identification of 150 Genital Pigmented Tumors: Towards a New Medical Organization of the Dermatologist, Non-dermatologist Articulation?

Performance of x400 dermatoscopic (results of expert dermatologists versus non-dermatologists physicians)

Performance of x400 dermatoscopic (results of expert dermatologists versus gynecologists)

Performance of x400 dermatoscopic (results of expert dermatologists versus general practitioners)

Performance of x400 dermatoscopic (results of gynecologists versus general practitioners)

Performance of x400 dermatoscopic (results of expert dermatologists versus skin Artificial intelligence software)

Performance of x400 dermatoscopic (results of dermatologists physicians versus skin Artificial intelligence software)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth	NCT02613325	Pigmented Skin ... Melanoma	Functional phot... Standard of car... Single cell pho...	18 Years -	Washington University School of Medicine
fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth	NCT02613325	Pigmented Skin ... Melanoma	Functional phot... Standard of car... Single cell pho...	18 Years -	Washington University School of Medicine
Spectral Diagnosis of Cutaneous Malignancy	NCT00476905	Skin Cancer	Spectral Diagno...	18 Years -	M.D. Anderson Cancer Center
Dermoscopy Augmented Histology Trial	NCT05004792	Melanoma Pigmented Lesio...	DermLoop Learn	-	Herlev Hospital
Dermoscopy Augmented Histology Trial	NCT05004792	Melanoma Pigmented Lesio...	DermLoop Learn	-	Herlev Hospital
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy	NCT04566302	Pigmented Lesio... Pigmented Skin ... Pigmented Moles Skin Lesion	SECM Skin Imagi...	18 Years -	Massachusetts General Hospital
Dermoscopy Augmented Histology Trial, Consensus Agreement Diagnosis Made by Dermatopathology Experts	NCT05712551	Melanoma (Skin) Pigmented Lesio...		-	Herlev Hospital
In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions	NCT01993654	Nevus Racial Melanosi... Primary Acquire... Conjunctival Ma...	HRT III with No...	18 Years -	Massachusetts Eye and Ear Infirmary
Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20	NCT06079619	Genital Tumor Pigmented Lesio...	Analysis of pho...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne

Spots Global Cancer Trial Database for pigmented lesions