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

NCT ID: NCT05402046

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-23
• Study Completion Date: 2024-04-30

Brief Summary

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

Detailed Description

This is a multicentre, low-intervention, prospective study. In several centers, patients will be selected into 4 cohorts:

1. Patients with complaints of skin neoplasm(s) who have sought the help of a specialist to remove it(them), and patients with an established clinical diagnosis of suspicious/doubtful skin neoplasm(s) who are scheduled to undergo excisional biopsy to verify the diagnosis;

2. Patients who have complaints about a skin neoplasm(s) and consider it (them) suspicious without using the ProRodinki application and who have asked for help from a specialist in order to remove it(them);

3. 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 sought help from a specialist in order to remove it (their) to verify the diagnosis;

4. Cohort 4 (prospective): patients with suspicious/doubtful skin neoplasm(s) detected during an objective examination by a specialist without using the ProRodinki application, and who are scheduled for an excisional biopsy to verify the diagnosis .

Patients scheduled for excisional biopsy of skin lesion(s) will be invited to participate in this study. After signing the informed voluntary consent form in the ProRodinki application, an account will be created for the patient, in which a questionnaire will be filled out, photo-documentation of the skin neoplasm(s) will be performed, and the generated report will be sent for evaluation by artificial intelligence. The response received from the application for each clinical case will be recorded and all neoplasms will be grouped according to the classification of the application. 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. Immediately before the excisional biopsy procedure, other non-invasive instrumental examinations (dermatoscopy, digital dermatoscopy) will be performed. 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. All neoplasms will be classified according to the MPATH-Dx classification, the 2018 WHO classification of skin tumors, and will be assigned an ICD-O-3 code. For invasive melanomas, the characteristics necessary to establish the morphological stage of pT will also be collected (see also the Study Procedures section). The conclusion of the intravital pathoanatomical examination will be photo-documented through the ProRodinki application and attached to the patient's account in the tab where the photo of the removed neoplasm is stored.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ProRodinki application test

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.

Group Type: EXPERIMENTAL

Mobile phone application "ProRodinki"

Intervention Type: 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

Interventions

Mobile phone application "ProRodinki"

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Privolzhsky Research Medical University

OTHER

Sponsor Role: collaborator

MelanomaPRO, Russia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lev V Demidov, Professor

Role: STUDY_DIRECTOR

The Russian Melanoma Professional Association (Melanoma.PRO)

Igor V Samoylenko

Role: STUDY_CHAIR

The Russian Melanoma Professional Association (Melanoma.PRO)

Locations

N.N.Blokhin Russian Cancer Research Center

Moscow, , Russia

Site Status: RECRUITING

Privolzhsky Research Medical Unversity

Nizhny Novgorod, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Oxana E Garanina, MD, PhD

Role: CONTACT

garaninaoe84@gmail.com

+7 908 757-45-60

Irena Shlivko, Professor

Role: CONTACT

Irshlivko@gmail.com

+7 908 757-45-60

Facility Contacts

Igor V Samoylenko, MD, PhD

Role: primary

i.samoylenko@ronc.ru

+74993242424

Kirill A Baryshnikov

Role: backup

k.baryshnikov@ronc.ru

+74993242424

Oxana E Garanina, MD, PhD

Role: primary

garaninaoe84@gmail.com

+7-831-439-09-43

Other Identifiers

MELPRO-0821

Identifier Type: -

Identifier Source: org_study_id