Clinical vAlidation of a MobilE appLication ("ProRodinki") in the Assessment of the maLignant skIn neoplAsms

NCT05402046 | Unknown

• 1 other identifier: MELPRO-0821
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 2

Brief Summary

A Multicenter, Prospective, Low-interventional Clinical Study Evaluating on mobile application validation ("ProRodinki") in assessing the risk of skin malignant neoplasms

Conditions

Melanoma (Skin); Nevus; Nevus, Spitz; Nevus Halo; Nevus, Pigmented; Basal Cell Carcinoma; Squamous Cell Carcinoma; Bowen's Disease; Melanoma in Situ; Spot Pigmented

Outcome Measures

Primary Outcomes (1)

• Sensitivity for malignant neoplasm 90% or higher

  Sensitivity will be calculated as the number of malignant neoplasms that are correctly classified, divided by all excised malignant neoplasms according to pathology report

  12 months

Study Arms (1)

ProRodinki application test

EXPERIMENTAL

Patients scheduled for excisional biopsy of skin lesion(s) will be invited to participate in this study. Photo-documentation of the skin neoplasm(s) in the ProRodinki application will be performed, and the generated report will be sent for evaluation by artificial intelligence. Following this procedure, an excisional biopsy of the lesion(s) will be scheduled. From the moment of inclusion in the study until the excisional biopsy, an interval of no more than 2-4 weeks is allowed. After excisional biopsy of the skin neoplasm(s), a routine intravital pathological examination with hematoxylin and eosin staining will be performed, if necessary, immunohistochemical and molecular genetic tests will be performed. The selected biosamples (paraffin blocks) will then be analyzed centrally by a morphologist.

Other: Mobile phone application "ProRodinki"

Interventions

Mobile phone application "ProRodinki" OTHER

Patient were underwent photography using mobile phone and tested application "ProRodinki"just before preplanned excisional or incisional biopsy. Application AI result than will be compared with pathology report by independent investigator

ProRodinki application test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General (for all cohorts):
• Signed informed consent form for participation in the study;
• The patient is scheduled for an incisional/excisional biopsy (or wide excision) of the skin lesion(s) within 2-4 weeks from entry into the study and the patient is able to tolerate this intervention;
• Cohort 1 (prospective): Patients complaining of a skin lesion(s) who sought specialist help to remove it(s) and patients with a clinical diagnosis of suspicious/doubtful skin lesion(s) who are scheduled for excisional biopsy to verify the diagnosis
• Patients who have complaints about skin neoplasm(s) and who have sought the physician to remove it(them);
• Clinically suspicious/doubtful skin neoplasm(s) detected during an objective examination by a dermatologist or oncologist without the use of instrumental diagnostic methods;
• Cohort 2 (prospective): Patients who complain of a skin neoplasm(s) and consider it(them) suspicious without using the ProRodinki application and seek specialist help to remove it(them)
• Patients who have complaints about a skin neoplasm(s) and consider it (them) suspicious without using the ProRodinki application and who have asked a physician to remove it(them);
• Clinically suspicious/doubtful skin neoplasm(s) detected during an objective examination by the patient without using the ProRodinki application;
• Cohort 3 (prospective): patients who complained of skin neoplasm(s) and who, using the ProRodinki application, received an answer that the neoplasm(s) is (are) suspicious/doubtful(s), and applied for help from a specialist in order to remove it (their) to verify the diagnosis
• Patients who have complaints about skin neoplasm(s), and who, using the ProRodinki application, received a response that the neoplasm(s) is (are) suspicious / doubtful (s), and referred to the physician to remove it (their) to verify the diagnosis;
• Clinically suspicious/doubtful skin neoplasm(s) detected by the patient when using the ProRodinki application;
• Cohort 4 (prospective): patients with suspicious/doubtful skin neoplasm(s) detected during an objective examination by a specialist without using the ProRodinki app, and who are scheduled for an excisional biopsy to verify the diagnosis
• Patients who have a suspicious/dubious skin neoplasm(s) detected during an objective examination by a specialist without using the ProRodinki application, and who are scheduled to undergo an excisional biopsy to verify the diagnosis;
• Clinically suspicious(s)/doubtful(s) skin neoplasm(s) detected during an objective examination by a dermatologist or oncologist without the use of instrumental diagnostic methods and the ProRodinki application;

You may not qualify if:

• General (all cohorts):
• Patient is NOT scheduled for excisional biopsy (or wide excision) of skin lesion(s) within 3 months of enrollment in the study OR the patient is unable to tolerate this intervention;
• Available intravital pathological confirmation of the nature of the neoplasm(s) (benign or malignant) that(s) are planned to be removed as part of this study;
• Neoplasm(s) located subcutaneously or in soft tissues and, according to clinical signs, having no connection with the skin;
• Allergic reaction to drugs used during incisional / excisional biopsy or wide excision;
• The patient's inability to follow study procedures (including contact with the investigator during observation visits) or other reasons that, in the opinion of the principal investigator, may become an obstacle to the patient's participation in the study;
• The age of the patient is younger than 18 years.

Sponsors & Collaborators

• MelanomaPRO, Russia: lead
• Privolzhsky Research Medical University: collaborator

Study Sites (2)

N.N.Blokhin Russian Cancer Research Center

Moscow, 115522, Russia

RECRUITING

Privolzhsky Research Medical Unversity

Nizhny Novgorod, 603005, Russia

RECRUITING

MeSH Terms

Conditions

Melanoma; Nevus; Nevus, Epithelioid and Spindle Cell; Nevus, Halo; Nevus, Pigmented; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Bowen's Disease

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Nevus, Spindle Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Study Officials

• Lev V Demidov, Professor

  The Russian Melanoma Professional Association (Melanoma.PRO)

  STUDY DIRECTOR

• Igor V Samoylenko

  The Russian Melanoma Professional Association (Melanoma.PRO)

  STUDY CHAIR

Central Study Contacts

Oxana E Garanina, MD, PhD

CONTACT

+7 908 757-45-60; garaninaoe84@gmail.com

Irena Shlivko, Professor

CONTACT

+7 908 757-45-60; Irshlivko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicentre, low-intervention, prospective study. Patients scheduled for excisional biopsy of skin lesion(s) will be invited to participate in this study. Photo-documentation of the skin neoplasm(s) in the ProRodinki application will be performed, and the generated report will be sent for evaluation by artificial intelligence. Following this procedure, an excisional biopsy of the lesion(s) will be scheduled. From the moment of inclusion in the study until the excisional biopsy, an interval of no more than 2-4 weeks is allowed. After excisional biopsy of the skin neoplasm(s), a routine intravital pathological examination with hematoxylin and eosin staining will be performed, if necessary, immunohistochemical and molecular genetic tests will be performed. The selected biosamples (paraffin blocks) will then be analyzed centrally by a morphologist.

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 2, 2022
• Study Start: April 23, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

RU (2)