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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Russian Academy of Medical Sciences
- Enrollment
- 350
- Locations
- 2
- Primary Endpoint
- Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination
- Last Updated
- 3 years ago
Overview
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".
Investigators
Igor Samoylenko
Principal Investigator, Senior Researcher, Department of Oncodermatology, MD, PhD
Blokhin's Russian Cancer Research Center
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
- •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
Exclusion Criteria
- •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
- •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
- •Cohort 3 (prospective):
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Describe the frequency of relapse (local, regional and systemic) within the observation period(up to 3 years)