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

May 29, 2022 updated by: MelanomaPRO, Russia

A Multicentre, Prospective, Low-intervention Clinical Trial to Validate a Mobile Application ("ProRodinki") in Assessing the Risk of Skin Malignancies

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

605

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Recruiting
        • N.N.Blokhin Russian Cancer Research Center
        • Contact:
        • Contact:
      • Nizhny Novgorod, Russian Federation, 603005
        • Recruiting
        • Privolzhsky Research Medical Unversity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity for malignant neoplasm 90% or higher
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MelanomaPRO, Russia

Collaborators

Privolzhsky Research Medical University

Investigators

  • Study Director: Lev V Demidov, Professor, The Russian Melanoma Professional Association (Melanoma.PRO)
  • Study Chair: Igor V Samoylenko, The Russian Melanoma Professional Association (Melanoma.PRO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

May 29, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 29, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MELPRO-0821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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