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

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ClinicalTrials.gov Identifier: NCT04353050
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
Blokhin's Russian Cancer Research Center
Information provided by (Responsible Party):
Igor Samoylenko, Blokhin's Russian Cancer Research Center

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".

Condition or disease Intervention/treatment Phase
Melanoma Melanoma (Skin) Moles Nevus Nevus, Blue Nevus, Pigmented Nevus, Spitz Nevi, Spindle Cell Nevi, Dysplastic Dysplastic Nevus Syndrome Mucosal Melanoma Mucosal Melanosis Procedure: Non-invasive adhesive system (patch) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Ambispective study with two retrospective cohorts and one prospective cohort
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : November 1, 2022


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
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




Primary Outcome Measures :
  1. Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination [ Time Frame: 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 :
  1. 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) [ Time Frame: 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

  2. Describe some parameters of the identified malignant tumors [ Time Frame: up to 12 months ]
  3. Describe the frequency of relapse (local, regional and systemic) within the observation period [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353050


Contacts
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Contact: Igor V Samoylenko, MD, PhD ‭+7 (909) 972-93-84‬ i.samoylenko@ronc.ru
Contact: Lev V Demidov, MD, PhD +74993241504 demidov.lev@gmail.com

Locations
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Russian Federation
Privolzhsky Research Medical University of the Ministry of Health of the Russian Federation Recruiting
Nizhny Novgorod, Russian Federation, 603155
Contact: Oxana E Garanina, MD, PhD    +78314390943    garaninaoe84@gmail.com   
Principal Investigator: Oxana E Garanina, MD, PhD         
Sub-Investigator: Irena L Shlivko, MD, PhD, DSc         
N.N. Blokhin Russian Cancer Research Center Recruiting
Moscow, Москва, Russian Federation, 115478
Contact: Igor Samoylenko, MD, PhD    +79099729384    i.samoylenko@ronc.ru   
Contact: Kirill Baryshnikov, MD, PhD    +79671751112    k.baryshnikov@ronc.ru   
Sub-Investigator: Lev V Demidov, MD, PhD         
Sub-Investigator: Kristina V Orlova, MD, PhD         
Sponsors and Collaborators
Russian Academy of Medical Sciences
Blokhin's Russian Cancer Research Center
Investigators
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Principal Investigator: Igor V Samoylenko, MD, PhD N.N. Blokhin Russian Cancer Research Center of Russian MoH
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Responsible Party: Igor Samoylenko, Principal Investigator, Senior Researcher, Department of Oncodermatology, MD, PhD, Blokhin's Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT04353050    
Other Study ID Numbers: MoleMed-0320
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Igor Samoylenko, Blokhin's Russian Cancer Research Center:
non-invasive diagnosis
melanoma
atypical moles
dysplastic nevi
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplastic Syndromes, Hereditary
Melanoma
Nevus
Nevus, Pigmented
Dysplastic Nevus Syndrome
Nevus, Blue
Nevus, Spindle Cell
Melanosis
Hyperplasia
Nevi and Melanomas
Pathologic Processes
Genetic Diseases, Inborn
Hyperpigmentation
Pigmentation Disorders
Skin Diseases