Atypical MOLes and Melanoma Early Detection Study (MoleMed) (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

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".

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Nevus; Nevus, Pigmented; Melanoma (Skin); Mucosal Melanoma; Moles; Dysplastic Nevus Syndrome; Nevus, Blue; Nevus, Spitz; Nevi, Spindle Cell; Nevi, Dysplastic; Mucosal Melanosis
• Intervention / Treatment: Procedure: Non-invasive adhesive system (patch)

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Igor V Samoylenko, MD, PhD; Phone Number: ‭+7 (909) 972-93-84‬; Email: i.samoylenko@ronc.ru
• Study Contact Backup: Name: Lev V Demidov, MD, PhD; Phone Number: +74993241504; Email: demidov.lev@gmail.com

Study Locations

• Russian Federation
  • Nizhny Novgorod, Russian Federation, 603155
    • Recruiting
    • Privolzhsky Research Medical University of the Ministry of Health of the Russian Federation
    • Contact: Oxana E Garanina, MD, PhD; Phone Number: +78314390943; Email: garaninaoe84@gmail.com
    • Principal Investigator: Oxana E Garanina, MD, PhD
    • Sub-Investigator: Irena L Shlivko, MD, PhD, DSc
  • Москва
    • Moscow, Москва, Russian Federation, 115478
      • Recruiting
      • N.N. Blokhin Russian Cancer Research Center
      • Sub-Investigator: Lev V Demidov, MD, PhD
      • Sub-Investigator: Kristina V Orlova, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Cohort 1 (retrospective):

• Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
• The presence of a paraffin block with a tumor suitable for molecular genetic analysis;
• Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
• Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);

• Known clinical data of the patient (gender, age, skin phototype), hereditary history, medical history and follow-up of treatment outcomes for at least 5 years

  2. Cohort 2 (retrospective):

• Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
• The presence of a paraffin block with a tumor suitable for molecular genetic analysis
• The presence of cytological preparations (at least 2 glasses) of the primary tumor with tumor material
• Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
• Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);

• A known medical history and follow-up of treatment outcomes for at least 6 months.

  3. Cohort 3 (prospective):

• Clinically (including any type of dermatoscopy or other non-invasive diagnostic methods) suspected diagnosis of malignant melanocytic neoplasm (or neoplasms) of the skin or mucous membranes (or lesion(s) with unclear malignant potential)
• The patient is scheduled to undergo an excision biopsy (or wide excision) of the neoplasm (s) of the skin or mucous membranes within 3 months from the date of inclusion in the study and the patient is able to tolerate this intervention;
• Signed Informed Consent Form

Exclusion Criteria:

Cohort 1:

• Unknown histological diagnosis (no information on the melanocytic nature of the neoplasm)
• Unsuitable for analysis paraffin block with a tumor or its absence
• Unknown history or lack of traceability after diagnosis within 5 years

• For the period of inclusion in the study (signing an informed consent form for living patients or an excision biopsy for deceased patients), the patient's age is under 18 years

  2. Cohort 2:

• Unknown histological diagnosis (no information on the melanocytic nature of the neoplasm)
• Unsuitable for analysis paraffin block with a tumor or its absence
• Unsuitable for analysis cytological preparations/smears (or the absence of tumor cells in cytological preparations)
• Unknown history or lack of traceability after diagnosis within 6 months.

• For the period of inclusion in the study (signing an informed consent form for living patients or an excision biopsy for deceased patients), the patient's age is under 18 years

  3. Cohort 3 (prospective):

• The patient is NOT scheduled to undergo an excision biopsy (or wide excision) of the neoplasm (s) of the skin or mucous membranes in the next 3 months since inclusion in the study OR the patient is not able to tolerate this intervention;
• The available morphological or cytological confirmation of the nature of the neoplasm (s) (benign or malignant), which (s) is planned to be removed in the framework of this study,
• Ulcerated neoplasms;
• Contact bleeding neoplasms;
• Non-melanocytic neoplasms;
• Neoplasms with an area of more than 5 sq. cm
• Neoplasms located subcutaneously or in soft tissues and, according to clinical signs, not associated with the skin
• Known allergy to any component of the applied adhesive system;
• Inability of the patient to follow the study procedures (including contacting the researcher during the follow-up visits) or other reasons that, in the opinion of the principal investigator, may become an obstacle for the patient to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Cohort 1 (retrospective); 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
No Intervention: Cohort 2 (retrospective); 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
Other: Cohort 3 (prospective); 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination	•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	April 2020 - Nov 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to other non-invasive diagnostic tools (i.e. dermoscopy)	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	up to 12 months
Describe some parameters of the identified malignant tumors		up to 12 months
Describe the frequency of relapse (local, regional and systemic) within the observation period		up to 3 years

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences
• Collaborators: Blokhin's Russian Cancer Research Center
• Investigators: Principal Investigator: Igor V Samoylenko, MD, PhD, N.N. Blokhin Russian Cancer Research Center of Russian MoH

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: melanoma; non-invasive diagnosis; atypical moles; dysplastic nevi
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Syndromes, Hereditary; Neuroendocrine Tumors; Nevi and Melanomas; Hyperpigmentation; Pigmentation Disorders; Hyperplasia; Melanoma; Melanosis; Nevus; Nevus, Pigmented; Dysplastic Nevus Syndrome; Nevus, Blue; Nevus, Epithelioid and Spindle Cell; Nevus, Spindle Cell
• Other Study ID Numbers: MoleMed-0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No