Melanoma (Skin)CAMELLIANCT05402046
Clinical vAlidation of a MobilE appLication ("ProRodinki") in the Assessment of the maLignant skIn neoplAsms
A study testing Mobile phone application "ProRodinki" in people with Melanoma (Skin) and Nevus, run by MelanomaPRO, Russia at 2 sites in Russia.
Trial summary
A Multicenter, Prospective, Low-interventional Clinical Study Evaluating on mobile application validation ("ProRodinki") in assessing the risk of skin malignant neoplasms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Nevus, Nevus, Spitz
- What is being tested?
- Mobile phone application "ProRodinki"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 2 sitesRussia
- Study dates
- 23 Apr 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients who have complaints about skin neoplasm(s) and who have sought the physician to remove it(them);
Show all 16Show fewer
- 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;
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
N.N.Blokhin Russian Cancer Research Center
Moscow, 115522
Igor V Samoylenko, MD, PhD, +74993242424, i.samoylenko@ronc.ru
Kirill A Baryshnikov, +74993242424, k.baryshnikov@ronc.ru
- Recruiting
Privolzhsky Research Medical Unversity
Nizhny Novgorod, 603005
Oxana E Garanina, MD, PhD, +7-831-439-09-43, garaninaoe84@gmail.com
About this study
Official title: 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
Read the detailed description
This is a multicentre, low-intervention, prospective study. In several centers, patients will be selected into 4 cohorts:
- 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;
- 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);
- 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;
- 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
- Being tested
- Mobile phone application "ProRodinki"
- Medical subject headings
- Melanoma, Nevus, Nevus, Epithelioid and Spindle Cell, Nevus, Halo, Nevus, Pigmented, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobile phone application "ProRodinki" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start23 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MelanomaPRO, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Privolzhsky Research Medical University
- Responsible party
- Sponsor
- Investigators
- Lev V Demidov, Professor, Study director, The Russian Melanoma Professional Association (Melanoma.PRO)Igor V Samoylenko, Study chair, The Russian Melanoma Professional Association (Melanoma.PRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402046
- Sponsor's protocol ID
- MELPRO-0821
- Acronym
- CAMELLIA
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Low-intervention Clinical Trial to Validate a Mobile Application ("ProRodinki") in Assessing the Risk of Skin Malignancies
- ClinicalTrials.gov ID
- NCT05402046
- Acronym / sponsor ID
- CAMELLIA / MELPRO-0821
- Conditions
- Melanoma (Skin), Nevus, Nevus, Spitz, Nevus Halo, Nevus, Pigmented, Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- MelanomaPRO, RussiaUniversity, hospital or other
- Collaborators
- Privolzhsky Research Medical University
- Study start
- 23 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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);
- 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;
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ProRodinki application test | Experimental | Other: Mobile phone application "ProRodinki"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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- Patients who have complaints about skin neoplasm(s) and who have sought the physician to remove it(them);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | ProRodinki application test |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lev V Demidov, Professor study director
The Russian Melanoma Professional Association (Melanoma.PRO)
Igor V Samoylenko study chair
The Russian Melanoma Professional Association (Melanoma.PRO)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone application "ProRodinki" in people with Melanoma (Skin) and Nevus, run by MelanomaPRO, Russia at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oxana E Garanina, MD, PhD (+7 908 757-45-60, garaninaoe84@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for malignant neoplasm 90% or higher (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.