Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Carcinoma, Basal Cell

Skin Neoplasms

Exanthema

Nevus, Pigmented

Bowen's Disease

Nevus

Nevus, Epithelioid and Spindle Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Diseases

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Nevus, Spindle Cell

Neuroendocrine Tumor

Neuroepithelioma

Patients scheduled for excisional biopsy of skin lesion(s) will be invited to participate in this study. Photo-documentation of the skin neoplasm(s) in the ProRodinki application will be performed, and the generated report will be sent for evaluation by artificial intelligence. Following this procedure, an excisional biopsy of the lesion(s) will be scheduled. From the moment of inclusion in the study until the excisional biopsy, an interval of no more than 2-4 weeks is allowed. After excisional biopsy of the skin neoplasm(s), a routine intravital pathological examination with hematoxylin and eosin staining will be performed, if necessary, immunohistochemical and molecular genetic tests will be performed. The selected biosamples (paraffin blocks) will then be analyzed centrally by a morphologist.

Patient were underwent photography using mobile phone and tested application "ProRodinki"just before preplanned excisional or incisional biopsy.

Application AI result than will be compared with pathology report by independent investigator

Mobile phone application "ProRodinki"

Oxana E Garanina, MD, PhD

Irena Shlivko, Professor

Igor V Samoylenko, MD, PhD

Kirill A Baryshnikov

Lev V Demidov, Professor

Igor V Samoylenko

A Multicenter, Prospective, Low-interventional Clinical Study Evaluating on mobile application validation ("ProRodinki") in assessing the risk of skin malignant neoplasms

This is a multicentre, low-intervention, prospective study. In several centers, patients will be selected into 4 cohorts:

1. Patients with complaints of skin neoplasm(s) who have sought the help of a specialist to remove it(them), and patients with an established clinical diagnosis of suspicious/doubtful skin neoplasm(s) who are scheduled to undergo excisional biopsy to verify the diagnosis;
2. Patients who have complaints about a skin neoplasm(s) and consider it (them) suspicious without using the ProRodinki application and who have asked for help from a specialist in order to remove it(them);
3. patients who have complaints about skin neoplasm(s) and who, using the ProRodinki application, received a response that the neoplasm(s) is (are) suspicious / doubtful (s), and sought help from a specialist in order to remove it (their) to verify the diagnosis;
4. Cohort 4 (prospective): patients with suspicious/doubtful skin neoplasm(s) detected during an objective examination by a specialist without using the ProRodinki application, and who are scheduled for an excisional biopsy to verify the diagnosis .

Patients scheduled for excisional biopsy of skin lesion(s) will be invited to participate in this study. After signing the informed voluntary consent form in the ProRodinki application, an account will be created for the patient, in which a questionnaire will be filled out, photo-documentation of the skin neoplasm(s) will be performed, and the generated report will be sent for evaluation by artificial intelligence. The response received from the application for each clinical case will be recorded and all neoplasms will be grouped according to the classification of the application. Following this procedure, an excisional biopsy of the lesion(s) will be scheduled. From the moment of inclusion in the study until the excisional biopsy, an interval of no more than 2-4 weeks is allowed. Immediately before the excisional biopsy procedure, other non-invasive instrumental examinations (dermatoscopy, digital dermatoscopy) will be performed. After excisional biopsy of the skin neoplasm(s), a routine intravital pathological examination with hematoxylin and eosin staining will be performed, if necessary, immunohistochemical and molecular genetic tests will be performed. The selected biosamples (paraffin blocks) will then be analyzed centrally by a morphologist. All neoplasms will be classified according to the MPATH-Dx classification, the 2018 WHO classification of skin tumors, and will be assigned an ICD-O-3 code. For invasive melanomas, the characteristics necessary to establish the morphological stage of pT will also be collected (see also the Study Procedures section). The conclusion of the intravital pathoanatomical examination will be photo-documented through the ProRodinki application and attached to the patient's account in the tab where the photo of the removed neoplasm is stored.

This is a multicentre, low-intervention, prospective study. Patients scheduled for excisional biopsy of skin lesion(s) will be invited to participate in this study. Photo-documentation of the skin neoplasm(s) in the ProRodinki application will be performed, and the generated report will be sent for evaluation by artificial intelligence. Following this procedure, an excisional biopsy of the lesion(s) will be scheduled. From the moment of inclusion in the study until the excisional biopsy, an interval of no more than 2-4 weeks is allowed. After excisional biopsy of the skin neoplasm(s), a routine intravital pathological examination with hematoxylin and eosin staining will be performed, if necessary, immunohistochemical and molecular genetic tests will be performed. The selected biosamples (paraffin blocks) will then be analyzed centrally by a morphologist.

Clinical vAlidation of a MobilE appLication ("ProRodinki") in the Assessment of the maLignant skIn neoplAsms

A Multicentre, Prospective, Low-intervention Clinical Trial to Validate a Mobile Application ("ProRodinki") in Assessing the Risk of Skin Malignancies

Sensitivity will be calculated as the number of malignant neoplasms that are correctly classified, divided by all excised malignant neoplasms according to pathology report

Privolzhsky Research Medical University

MelanomaPRO, Russia

Study group: 16 children under 18 years undergoing systemic chemotherapy

Control group: 16 age and sex matched healthy children under 18 years

Barbara Binder, MD

Changes in nevus count in 16 children (8m, 8f) aged between 2 and 17 years (median:8 years) suffering from different malignancies were examined every three months during a one-year period after starting chemotherapy. An age and sex matched control group underwent the same skin examinations.At the start of our study, the range of number of nevi in the chemotherapy group was 0-133, in the control group 2-199.

Objectives:

Patients given chemotherapy because of different malignancies have an increased susceptibility to cutaneous tumours and infection and a change of number of nevi during treatment is discussed. We investigated wether total nevi count changes in children undergoing chemotherapy. Therefore 16 (8m, 8f) children suffering from leukaemia (11), lymphoma (2), adenosarcoma of the kidney (1), Ewing´s sarcoma (1) and neuroblastoma (1) aged between 2 and 17 years (median:8 years), under chemotherapy at the pediatric department of oncology, were examined at the beginning and 9-12 months after starting chemotherapy. As control group age and sex matched children of the local population were used.

Materials and Methods:

At the beginning of chemotherapy the nevi were counted on the total body. All nevi were larger in diameter than 1mm and as melanocytic lesion identifiable. Clinical and dermoscopic photographs were taken of every nevus. If the patient had more than 50 nevi, only nevi on the face, right arm, upper back and the buttocks were documented. Reassessment was repeated every 3 month.

Conclusion:

In our patients under chemotherapy during one year the development of new nevi is similar to sex and age matched children of the general population. During this short period development of nevi seems not to be influenced by chemotherapy.

Melanocytic Nevi in Children Under Chemotherapy

Melanocytic-Nevi-Counts During Chemotherapy of Children With Malignancies.

Medical University of Graz

Binder Barbara, MD

Keratosis, Actinic

Keratosis

Keratosis, Seborrheic

consecutive enrollment of newly referred skin tumour patients

comparison of four imaging technologies in skin tumour diagnosis

optical coherence tomography

Aim of study:

To collect data for a new image-guided diagnostic algoritm, enabling the investigators to differentiate more precisely between benign and malignant pigmented tumours at the bedside. This study will include 60 patients with four different pigmented tumours: seborrheic keratosis (n=15), dermal nevi (n=15), pigmented basal cell carcinomas (n=15), and malignant melanomas (n=15), these four types of tumours are depicted in Fig.1, and all lesions will be scanned by four imaging technologies, recruiting patients from Sept 2019 to May 2020. In vivo reflectance confocal microscopy (CM) will be used to diagnose pigmented tumours at a cellular level and provide micromorphological information5;6. Flourescent CM will be applied to enhance contrast in surrounding tissue/tumours. Optical coherence tomography (OCT), doppler high-frequency ultrasound (HIFU) and photoacustic imaging (also termed MSOT, multispectral optoacustic tomography) will be used to measure tumour thickness, to delineate tumours and analyze blood flow in blood vessels. Potential diagnostic features from each lesion type will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology

Study design The prospective non-blinded clinical study will include with seborrheic keratosis (n=15), dermal nevi (n=15), pigmented or dark basal cell carcinomas (n=15), and malignant melanomas (n=15) referred to or diagnosed at Dept. of Dermatology, Bispebjerg Hospital. All tumours are histologically verified by skin biopsy. To explore clinical feasibility and diagnostic accuracy of four different skin imaging technologies all patients will be scanned by an experienced examiner in one 2-hour session. If patients demonstrate more than one skin tumour within the same anatomical location, all lesions will be included and scanned. Lesions in other anatomical areas of the same patient will not be included. The total extra time spend in the department to participate in this study will be approximately 2-3 hours for each patient. Only one visit is required to participate. The skin tumors in patients enrolled will subsequently be treated according to hospital and national guidelines.

Background: A bedside examination of a skin tumours using advanced imaging technology is considered a valuable future tool for Dermatologists. The investigators vision is to provide image guided skin cancer therapy to all patients with skin tumours. This study compares clinical feasibility and diagnostic accuracy of four different imaging technologies applied in a fast-track bedside analysis of various skin tumours; four different types, 2 benign and 2 malignant types.

It is also hypothesized that:

* Due to higher resolution UHR-OCT may have higher diagnostic accuracy than C-OCT.
* Doppler HIFU and optoacustic imaging diagnosis may be more accurate in skin tumours thicker than 1-2 mm compared to diagnosis based on OCT imaging.
* The cellular resolution of RCM and the detailed blood flow information acquired from photoacustic imaging may supplement clinical decision making and increase diagnostic accuracy compared to only OCT or only HIFU.

Study objectives

Primary objective:

This study explores the clinical utility of four skin imaging technologies: scanning time, clinical feasibility (does the skin tumour fit into the scanning probe) and diagnostic accuracy. The investigators examine patients with four different common skin tumour types referred to Dept of Dermatology, BFH using four different advanced imaging technologies; five different tools as investigators apply two different OCT-systems.

Secondary outcome measures:

* To measure diagnostic accuracy of index tests (OCT, RCM, HIFU and photoacoustic imaging)
* To measure tumor size by OCT, photoacoustic imaging and HIFU
* To explore if UHR-OCT detects features in tumors that C-OCT cannot detect.
* To explore if information from dynamic C-OCT images of dermal blood vessels inside the skin tumour increases diagnostic accuracy
* To explore if information from doppler ultrasound images of dermal vessels inside the tumour increases diagnostic accuracy
* To explore if information from photoacoustic imaging of dermal vessels inside the tumour increases diagnostic accuracy
* To report potential decreased time delay from first visit to efficient skin cancer treatment
* To record survival rates
* To record treatment types and number of therapeutic sessions (e.g. operations)
* To report potential adverse device events
* To report patient satisfaction of scanning procedures

Evaluation of skin tumours All skin tumours will be evaluated clinically, by two different OCT systems (C-OCT and UHR-OCT), by RCM, by photoacoustic imaging and doppler HIFU. Skin biopsies will be performed according to standard hospital procedures. Skin punch biopsies from skin tumours are required for treatment planning and is not part of this research project. Accordingly, a skin biopsy will be performed as part of the treatment plan independent of whether the patient is recruited or not.

Imaging Technologies In vivo reflectance confocal microscopy (CM) will be used to diagnose pigmented tumours at a cellular level and provide micromorphological information5;6. Flourescent CM will be applied to enhance contrast in surrounding tissue/tumours. Optical coherence tomography (OCT), doppler high-frequency ultrasound (HIFU) and photoacustic imaging (also termed MSOT, multispectral optoacustic tomography) will be used to measure tumour thickness, to delineate tumours and analyze blood flow in blood vessels. Potential diagnostic features from lesion types will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology The imaging methods OCT, RCM and doppler ultrasound, are technologies that are routinely used in the clinic at Dept of Dermatology, BFH and all investigators are highly trained in using the scanners. The UHR-OCT is a prototype and the photoacoustic system is a brand-new clinical device. OCT, RCM and ultrasound examinations are performed in a darkened room. The images of all patients will be saved in a digital archiving computer system for subsequent scoring and further evaluation.

Fast Track Diagnosis of Skin Cancer by Advanced Imaging

Fast Track Diagnosis of Skin Tumours by Four Different Advanced Imaging Technologies - a Clinical Study

The images file data will be very large and will be situated on the hospital server. We cannot legally share these files.

Sensitivity is expressed in percentage and defines the proportion of true positive subjects with the disease in a total group of subjects with the disease (TP/TP+FN). Sensitivity is defined as the probability of getting a positive test result in subjects with the disease (T+\|B+). Specificity is a measure of diagnostic test´s accuracy, complementary to sensitivity. It is defined as a proportion of subjects without the disease with negative test result in total of subjects without disease (TN/TN+FP). Sensitivity and specificity are reported in percent

expressed in arbitrary units in OCT volume scans and in volume densities/second in doppler ultrasound images

Expressed as duration of time from diagnosis till initial treatment in number of days

For each study participant treatment types are listed in numerical numbers and so is the number of treatment sessions counted and listed for each individual participant in this trial

A questionnaire with qualitative questions (How did you like being scanned?) and quantitative questions: on a scale from 0-10 how painful was the scanning procedure)

University Hospital Bispebjerg and Frederiksberg

MD, PhD, Ass. Prof., Chief Consultant

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Syndrome

Melanosis

Pigmentation Disorders

Dysplastic Nevus Syndrome

Nevus, Blue

Hyperplasia

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Hyperpigmentation

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anesthetics

Formaldehyde

Only data from medical records and formalin-fixed paraffin-embedded tissue blocks will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio

Only data from medical records, formalin-fixed paraffin-embedded tissue blocks and cytologic slides will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio

Patients with pigmented lesions on the skin or mucosa who are referred for excisional biopsy will be offered to apply investigated non-invasive adhesive system on their lesion just before the excisional biopsy. After biopsy cytological slides and FFPE tissue blocks will be prepared. All three types of obtained samples will be investigated separately (adhesive patches, cytologic slides and FFPE tissue blocks) for genetic markers whereas cytologic slides and FFPE tissue blocks will be processed also routinely and regular cytologic and histopathologic report will be generated.

The already registered on the market adhesive skin patch will be applied and removed for several times on the pigmented skin (or mucosal) lesion just before the preplanned excisional biopsy after local anaesthesia have been already administered. Excisional biopsy and local anaesthesia are not the part of this study and will be carried out according to local practice

Non-invasive adhesive system (patch)

Lev V Demidov, MD, PhD

Irena L Shlivko, MD, PhD, DSc

Igor Samoylenko, MD, PhD

Kirill Baryshnikov, MD, PhD

Kristina V Orlova, MD, PhD

This is a multicenter, ambispective, low-interventional clinical study evaluating molecular genetic markers for non-invasive differential diagnosis of benign and malignant pigmented skin and mucosal neoplasms. In retrospective cohorts genetics markers will be identified. In prospective cohort non-invasive adhesive system will be tested to identify malignant or benign lesions with prespecified sensitivity and specificity compared to other non-invasive techniques (i.e. dermoscopy) and using histopathological examination as a "golden standard".

Ambispective study with two retrospective cohorts and one prospective cohort

Atypical MOLes and Melanoma Early Detection Study (MoleMed)

A Multicenter, Ambispective, Low-interventional Clinical Study Evaluating Molecular Genetic Markers for Non-invasive Differential Diagnosis of Benign and Malignant Pigmented Skin and Mucosal Neoplasms

•Assessment of the sensitivity and specificity of a complex of molecular genetic studies applicable for non-invasive differential diagnosis of benign and malignant melanocytic neoplasms of the skin and mucous membranes in comparison with a standard histological examination

Assessment of the sensitivity, specificity, positive and negative prognostic significance of the developed molecular genetic method for non-invasive differential diagnosis of benign and malignant pigmented neoplasms of the skin and mucous membranes in comparison with clinical diagnosis with an naked eye by an oncologist or dermatologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical vAlidation of a MobilE appLication ("ProRodinki") in the Assessment of the maLignant skIn neoplAsms	NCT05402046	Melanoma (Skin) Nevus Nevus, Spitz Nevus Halo Nevus, Pigmente... Basal Cell Carc... Squamous Cell C... Bowen's Disease Melanoma in Sit... Spot Pigmented	Mobile phone ap...	18 Years -	MelanomaPRO, Russia
Melanocytic Nevi in Children Under Chemotherapy	NCT00600431	Nevus, Pigmente...		- 18 Years	Medical University of Graz
Fast Track Diagnosis of Skin Cancer by Advanced Imaging	NCT04229277	Malignant Melan... Nevus, Pigmente... Basal Cell Carc... Seborrheic Kera...	optical coheren...	18 Years -	University Hospital Bispebjerg and Frederiksberg
Atypical MOLes and Melanoma Early Detection Study (MoleMed)	NCT04353050	Melanoma Melanoma (Skin) Moles Nevus Nevus, Blue Nevus, Pigmente... Nevus, Spitz Nevi, Spindle C... Nevi, Dysplasti... Dysplastic Nevu... Mucosal Melanom... Mucosal Melanos...	Non-invasive ad...	18 Years -	Russian Academy of Medical Sciences
Clinical vAlidation of a MobilE appLication ("ProRodinki") in the Assessment of the maLignant skIn neoplAsms	NCT05402046	Melanoma (Skin) Nevus Nevus, Spitz Nevus Halo Nevus, Pigmente... Basal Cell Carc... Squamous Cell C... Bowen's Disease Melanoma in Sit... Spot Pigmented	Mobile phone ap...	18 Years -	MelanomaPRO, Russia
Atypical MOLes and Melanoma Early Detection Study (MoleMed)	NCT04353050	Melanoma Melanoma (Skin) Moles Nevus Nevus, Blue Nevus, Pigmente... Nevus, Spitz Nevi, Spindle C... Nevi, Dysplasti... Dysplastic Nevu... Mucosal Melanom... Mucosal Melanos...	Non-invasive ad...	18 Years -	Russian Academy of Medical Sciences
Fast Track Diagnosis of Skin Cancer by Advanced Imaging	NCT04229277	Malignant Melan... Nevus, Pigmente... Basal Cell Carc... Seborrheic Kera...	optical coheren...	18 Years -	University Hospital Bispebjerg and Frederiksberg

Spots Global Cancer Trial Database for nevus, pigmented