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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)
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
April 13, 2020
Last Updated
June 12, 2022
Sponsor
Russian Academy of Medical Sciences
Collaborators
Blokhin's Russian Cancer Research Center
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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
Arm Title
Cohort 2 (retrospective)
Arm Type
No Intervention
Arm Description
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
Arm Title
Cohort 3 (prospective)
Arm Type
Other
Arm Description
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.
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
•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
Time Frame
April 2020 - Nov 2022
Secondary 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 other non-invasive diagnostic tools (i.e. dermoscopy)
Description
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
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
No
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
Email
i.samoylenko@ronc.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Lev V Demidov, MD, PhD
Phone
+74993241504
Email
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
Email
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
Email
i.samoylenko@ronc.ru
First Name & Middle Initial & Last Name & Degree
Kirill Baryshnikov, MD, PhD
Phone
+79671751112
Email
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
No

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Atypical MOLes and Melanoma Early Detection Study (MoleMed)

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