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Atypical MOLes and Melanoma Early Detection Study (MoleMed)

NCT04353050 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-06-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    collaborator OTHER

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Igor V Samoylenko, MD, PhD · N.N. Blokhin Russian Cancer Research Center of Russian MoH

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-01-01
Completion
2023-11-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353050 on ClinicalTrials.gov