Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Melanoma

Melanosis

Pigmentation Disorders

Dysplastic Nevus Syndrome

Nevus, Pigmented

Nevus

Nevus, Spindle Cell

Nevus, Blue

Nevus, Epithelioid and Spindle Cell

Hyperplasia

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Hyperpigmentation

Neuroendocrine Tumor

Neuroepithelioma

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)

Igor V Samoylenko, MD, PhD

Lev V Demidov, MD, PhD

Oxana E Garanina, 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

Blokhin's Russian Cancer Research Center

Russian Academy of Medical Sciences

Principal Investigator, Senior Researcher, Department of Oncodermatology, MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

Spots Global Cancer Trial Database for nevi, spindle cell