Atypical MOLes and Melanoma Early Detection Study (MoleMed)

NCT04353050 | Unknown

• 1 other identifier: MoleMed-0320
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

non-invasive diagnosis; melanoma; atypical moles; dysplastic nevi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

  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

Study Arms (3)

Cohort 1 (retrospective)

NO INTERVENTION

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

Cohort 2 (retrospective)

NO INTERVENTION

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

Cohort 3 (prospective)

OTHER

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)

Interventions

Non-invasive adhesive system (patch) PROCEDURE

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

Cohort 3 (prospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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
• \. 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);
• A known medical history and follow-up of treatment outcomes for at least 6 months.
• \. 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)
• Signed Informed Consent Form

You may not qualify if:

• 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
• \. 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.
• \. Cohort 3 (prospective):
• 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

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead
• Blokhin's Russian Cancer Research Center: collaborator

Study Sites (2)

N.N. Blokhin Russian Cancer Research Center

Moscow, Moscow, 115478, Russia

RECRUITING

Privolzhsky Research Medical University of the Ministry of Health of the Russian Federation

Nizhny Novgorod, 603155, Russia

RECRUITING

MeSH Terms

Conditions

Melanoma; Nevus; Nevus, Blue; Nevus, Pigmented; Nevus, Epithelioid and Spindle Cell; Nevus, Spindle Cell; Dysplastic Nevus Syndrome

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Igor V Samoylenko, MD, PhD

  N.N. Blokhin Russian Cancer Research Center of Russian MoH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor V Samoylenko, MD, PhD

CONTACT

‭+7 (909) 972-93-84‬; i.samoylenko@ronc.ru

Lev V Demidov, MD, PhD

CONTACT

+74993241504; demidov.lev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Researcher, Department of Oncodermatology, MD, PhD

Model Details: Ambispective study with two retrospective cohorts and one prospective cohort

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 20, 2020
• Study Start: April 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)