A Multicentre, Prospective, Low-intervention Clinical Trial to Validate a Mobile Application ("ProRodinki") in Assessing the Risk of Skin Malignancies
Trial ID: NCT05402046
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-04-23
Completion date: 2024-04
Sponsor: MelanomaPRO, Russia
Collaborators: Privolzhsky Research Medical University
Conditions: Melanoma (Skin); Nevus; Nevus, Spitz; Nevus Halo; Nevus, Pigmented; Basal Cell Carcinoma; Squamous Cell Carcinoma; Bowen's Disease; Melanoma in Situ; Spot Pigmented
Interventions: Mobile phone application "ProRodinki"
Locations: N.N.Blokhin Russian Cancer Research Center; Privolzhsky Research Medical Unversity
Countries: Russia; Russia
Enrollment: 605
Age range: 18 Years - None
Sex: ALL

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

Eligibility criteria:
Inclusion Criteria:

General (for all cohorts):

* Signed informed consent form for participation in the study;
* Age of the patient over 18 years of age at the time of inclusion in the study (at the time of signing the consent form).
* 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

1. Patients who have complaints about skin neoplasm(s) and who have sought the physician to remove it(them);
2. 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)

1. 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);
2. 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

1. 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;
2. 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

1. 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;
2. 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;

Exclusion Criteria:

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;
* For the period of inclusion in the study, do not sign the informed consent form;
* The age of the patient is younger than 18 years.

Outcomes:
Sensitivity for malignant neoplasm 90% or higher