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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

Tracking Information
First Submitted Date  ICMJE April 13, 2020
First Posted Date  ICMJE April 20, 2020
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • 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
  • Describe some parameters of the identified malignant tumors [ Time Frame: up to 12 months ]
  • Describe the frequency of relapse (local, regional and systemic) within the observation period [ Time Frame: up to 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atypical MOLes and Melanoma Early Detection Study (MoleMed)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Melanoma
  • Melanoma (Skin)
  • Moles
  • Nevus
  • Nevus, Blue
  • Nevus, Pigmented
  • Nevus, Spitz
  • Nevi, Spindle Cell
  • Nevi, Dysplastic
  • Dysplastic Nevus Syndrome
  • Mucosal Melanoma
  • Mucosal Melanosis
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Non-invasive adhesive system (patch)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2020)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04353050
Other Study ID Numbers  ICMJE MoleMed-0320
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Igor Samoylenko, Blokhin's Russian Cancer Research Center
Study Sponsor  ICMJE Russian Academy of Medical Sciences
Collaborators  ICMJE Blokhin's Russian Cancer Research Center
Investigators  ICMJE
Principal Investigator: Igor V Samoylenko, MD, PhD N.N. Blokhin Russian Cancer Research Center of Russian MoH
PRS Account Russian Academy of Medical Sciences
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP