Atypical MOLes and Melanoma Early Detection Study (MoleMed)

Not Applicable

• Conditions: Melanoma (Skin); Moles; Nevus; Nevus, Spitz; Nevi, Spindle Cell; Nevi, Dysplastic; Mucosal Melanoma; Melanoma; Nevus, Blue; Nevus, Pigmented
• Interventions: Procedure: Non-invasive adhesive system (patch)

• Registration Number: NCT04353050
• Lead Sponsor: Russian Academy of Medical Sciences

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-14
• Primary Completion: 2023-01-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3 (prospective)	Non-invasive adhesive system (patch)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Describe some parameters of the identified malignant tumors	up to 12 months
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	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
Describe the frequency of relapse (local, regional and systemic) within the observation period	up to 3 years

Trial Locations

Locations (2)

N.N. Blokhin Russian Cancer Research Center; 🇷🇺 Moscow, Москва, Russian Federation

Privolzhsky Research Medical University of the Ministry of Health of the Russian Federation; 🇷🇺 Nizhny Novgorod, Russian Federation