NCT04353050

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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".

Conditions

• Melanoma
• Melanoma (Skin)
• Moles
• Nevus
• Nevus, Blue
• Nevus, Pigmented
• Nevus, Spitz
• Nevi, Spindle Cell
• Nevi, Dysplastic
• Dysplastic Nevus Syndrome
• Mucosal Melanoma
• Mucosal Melanosis

Interventions

Type	Name	Description
PROCEDURE	Non-invasive adhesive system (patch)	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

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-01-01
• Completion: 2023-11-01
• First posted: 2020-04-20
• Last updated: 2022-06-14

Locations

2 sites across 1 country: Russia