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Atypical MOLes and Melanoma Early Detection Study (MoleMed) (MoleMed)

Primary Purpose

Melanoma, Melanoma (Skin), Moles

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Non-invasive adhesive system (patch)

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring non-invasive diagnosis, melanoma, atypical moles, dysplastic nevi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Privolzhsky Research Medical University of the Ministry of Health of the Russian FederationRecruiting
N.N. Blokhin Russian Cancer Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Arm Label

Cohort 1 (retrospective)

Cohort 2 (retrospective)

Cohort 3 (prospective)

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Describe some parameters of the identified malignant tumors

Describe the frequency of relapse (local, regional and systemic) within the observation period

Full Information

NCT ID

NCT04353050

First Posted

April 13, 2020

Last Updated

June 12, 2022

Sponsor

Russian Academy of Medical Sciences

Collaborators

Blokhin's Russian Cancer Research Center

1. Study Identification

Unique Protocol Identification Number

NCT04353050

Brief Title

Atypical MOLes and Melanoma Early Detection Study (MoleMed)

Acronym

MoleMed

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Russian Academy of Medical Sciences

Collaborators

Blokhin's Russian Cancer Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Ambispective study with two retrospective cohorts and one prospective cohort

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 (retrospective)

Arm Type

No Intervention

Arm Description

Arm Title

Cohort 2 (retrospective)

Arm Type

No Intervention

Arm Description

Arm Title

Cohort 3 (prospective)

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Non-invasive adhesive system (patch)

Intervention Description

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

Primary Outcome Measure Information:

Title

Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination

Description

Time Frame

April 2020 - Nov 2022

Secondary Outcome Measure Information:

Title

Description

Time Frame

up to 12 months

Title

Describe some parameters of the identified malignant tumors

Time Frame

up to 12 months

Title

Describe the frequency of relapse (local, regional and systemic) within the observation period

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Igor V Samoylenko, MD, PhD

Phone

‭+7 (909) 972-93-84‬

i.samoylenko@ronc.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Lev V Demidov, MD, PhD

Phone

+74993241504

demidov.lev@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Igor V Samoylenko, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Nizhny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oxana E Garanina, MD, PhD

Phone

+78314390943

garaninaoe84@gmail.com

First Name & Middle Initial & Last Name & Degree

Oxana E Garanina, MD, PhD

First Name & Middle Initial & Last Name & Degree

Irena L Shlivko, MD, PhD, DSc

Facility Name

N.N. Blokhin Russian Cancer Research Center

City

Moscow

State/Province

Москва

ZIP/Postal Code

115478

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Igor Samoylenko, MD, PhD

Phone

+79099729384

i.samoylenko@ronc.ru

First Name & Middle Initial & Last Name & Degree

Kirill Baryshnikov, MD, PhD

Phone

+79671751112

k.baryshnikov@ronc.ru

First Name & Middle Initial & Last Name & Degree

Lev V Demidov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Kristina V Orlova, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Atypical MOLes and Melanoma Early Detection Study (MoleMed)

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