MelanomaMoleMedNCT04353050
Atypical MOLes and Melanoma Early Detection Study (MoleMed)
A study testing Non-invasive adhesive system (patch) in people with Melanoma and Melanoma (Skin), run by Russian Academy of Medical Sciences at 2 sites in Russia.
Trial summary
This is a multicenter, ambispective, low-interventional clinical study evaluating molecular genetic markers for non-invasive differential diagnosis of benign and malignant pigmented skin and mucosal neoplasms. In retrospective cohorts genetics markers will be identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Melanoma (Skin), Moles
- What is being tested?
- Non-invasive adhesive system (patch)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Apr 2020to 1 Nov 2023
- 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
- Cohort 1 (retrospective):
- Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
- The presence of a paraffin block with a tumor suitable for molecular genetic analysis;
- Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
- Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);
- Known clinical data of the patient (gender, age, skin phototype), hereditary history, medical history and follow-up of treatment outcomes for at least 5 years
Show all 17Show fewer
- 2. Cohort 2 (retrospective):
- Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
- The presence of a paraffin block with a tumor suitable for molecular genetic analysis
- The presence of cytological preparations (at least 2 glasses) of the primary tumor with tumor material
- Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
- Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);
- A known medical history and follow-up of treatment outcomes for at least 6 months.
- 3. Cohort 3 (prospective):
- Clinically (including any type of dermatoscopy or other non-invasive diagnostic methods) suspected diagnosis of malignant melanocytic neoplasm (or neoplasms) of the skin or mucous membranes (or lesion(s) with unclear malignant potential)
- The patient is scheduled to undergo an excision biopsy (or wide excision) of the neoplasm (s) of the skin or mucous membranes within 3 months from the date of inclusion in the study and the patient is able to tolerate this intervention;
- Signed Informed Consent Form
Who cannot join
- Cohort 1:
- Unknown histological diagnosis (no information on the melanocytic nature of the neoplasm)
- Unsuitable for analysis paraffin block with a tumor or its absence
- Unknown history or lack of traceability after diagnosis within 5 years
- For the period of inclusion in the study (signing an informed consent form for living patients or an excision biopsy for deceased patients), the patient's age is under 18 years
- 2. Cohort 2:
Show all 21Show fewer
- Unknown histological diagnosis (no information on the melanocytic nature of the neoplasm)
- Unsuitable for analysis paraffin block with a tumor or its absence
- Unsuitable for analysis cytological preparations/smears (or the absence of tumor cells in cytological preparations)
- Unknown history or lack of traceability after diagnosis within 6 months.
- For the period of inclusion in the study (signing an informed consent form for living patients or an excision biopsy for deceased patients), the patient's age is under 18 years
- 3. Cohort 3 (prospective):
- The patient is NOT scheduled to undergo an excision biopsy (or wide excision) of the neoplasm (s) of the skin or mucous membranes in the next 3 months since inclusion in the study OR the patient is not able to tolerate this intervention;
- The available morphological or cytological confirmation of the nature of the neoplasm (s) (benign or malignant), which (s) is planned to be removed in the framework of this study,
- Ulcerated neoplasms;
- Contact bleeding neoplasms;
- Non-melanocytic neoplasms;
- Neoplasms with an area of more than 5 sq. cm
- Neoplasms located subcutaneously or in soft tissues and, according to clinical signs, not associated with the skin
- Known allergy to any component of the applied adhesive system;
- Inability of the patient to follow the study procedures (including contacting the researcher during the follow-up visits) or other reasons that, in the opinion of the principal investigator, may become an obstacle for the patient to participate in the study
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
N.N. Blokhin Russian Cancer Research Center
Moscow, Moscow, 115478
Igor Samoylenko, MD, PhD, +79099729384, i.samoylenko@ronc.ru
Kirill Baryshnikov, MD, PhD, +79671751112, k.baryshnikov@ronc.ru
- Recruiting
Privolzhsky Research Medical University of the Ministry of Health of the Russian Federation
Nizhny Novgorod, 603155
Oxana E Garanina, MD, PhD, +78314390943, garaninaoe84@gmail.com
Oxana E Garanina, MD, PhD
About this study
Official title: A Multicenter, Ambispective, Low-interventional Clinical Study Evaluating Molecular Genetic Markers for Non-invasive Differential Diagnosis of Benign and Malignant Pigmented Skin and Mucosal Neoplasms
This is a multicenter, ambispective, low-interventional clinical study evaluating molecular genetic markers for non-invasive differential diagnosis of benign and malignant pigmented skin and mucosal neoplasms. In retrospective cohorts genetics markers will be identified. In prospective cohort non-invasive adhesive system will be tested to identify malignant or benign lesions with prespecified sensitivity and specificity compared to other non-invasive techniques (i.e. dermoscopy) and using histopathological examination as a "golden standard".
- Conditions
- Melanoma, Melanoma (Skin), Moles, Nevus, Nevus, Blue, Nevus, Pigmented
- Being tested
- Non-invasive adhesive system (patch)
- Keywords
- non-invasive diagnosis, melanoma, atypical moles, dysplastic nevi
- Medical subject headings
- Melanoma, Nevus, Nevus, Blue, Nevus, Pigmented, Nevus, Epithelioid and Spindle Cell, Nevus, Spindle Cell, Dysplastic Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive adhesive system (patch)Procedure or surgery
The already registered on the market adhesive skin patch will be applied and removed for several times on the pigmented skin (or mucosal) lesion just before the preplanned excisional biopsy after local anaesthesia have been already administered. Excisional biopsy and local anaesthesia are not the part of this study and will be carried out according to local practice
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (retrospective) | No intervention | Only data from medical records and formalin-fixed paraffin-embedded tissue blocks will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio |
| Cohort 2 (retrospective) | No intervention | Only data from medical records, formalin-fixed paraffin-embedded tissue blocks and cytologic slides will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio |
| Cohort 3 (prospective) | Other | Patients with pigmented lesions on the skin or mucosa who are referred for excisional biopsy will be offered to apply investigated non-invasive adhesive system on their lesion just before the excisional biopsy. After biopsy cytological slides and FFPE tissue blocks will be prepared. All three types of obtained samples will be investigated separately (adhesive patches, cytologic slides and FFPE tissue blocks) for genetic markers whereas cytologic slides and FFPE tissue blocks will be processed also routinely and regular cytologic and histopathologic report will be generated. Receives: Procedure: Non-invasive adhesive system (patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination
•Assessment of the sensitivity and specificity of a complex of molecular genetic studies applicable for non-invasive differential diagnosis of benign and malignant melanocytic neoplasms of the skin and mucous membranes in comparison with a standard histological examination
Measured: April 2020 - Nov 2022
Secondary outcomes (3)
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to other non-invasive diagnostic tools (i.e. dermoscopy)
Assessment of the sensitivity, specificity, positive and negative prognostic significance of the developed molecular genetic method for non-invasive differential diagnosis of benign and malignant pigmented neoplasms of the skin and mucous membranes in comparison with clinical diagnosis with an naked eye by an oncologist or dermatologist
Measured: up to 12 months
Describe some parameters of the identified malignant tumors
Measured: up to 12 months
Describe the frequency of relapse (local, regional and systemic) within the observation period
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Ambispective study with two retrospective cohorts and one prospective cohort
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Blokhin's Russian Cancer Research Center
- Responsible party
- Principal investigator, Igor Samoylenko, Blokhin's Russian Cancer Research Center
- Investigators
- Igor V Samoylenko, MD, PhD, Principal investigator, N.N. Blokhin Russian Cancer Research Center of Russian MoH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353050
- Sponsor's protocol ID
- MoleMed-0320
- Acronym
- MoleMed
- Status last verified
- Jun 2022
- First submitted
- 13 Apr 2020
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Ambispective, Low-interventional Clinical Study Evaluating Molecular Genetic Markers for Non-invasive Differential Diagnosis of Benign and Malignant Pigmented Skin and Mucosal Neoplasms
- ClinicalTrials.gov ID
- NCT04353050
- Acronym / sponsor ID
- MoleMed / MoleMed-0320
- Conditions
- Melanoma, Melanoma (Skin), Moles, Nevus, Nevus, Blue, Nevus, Pigmented
- Keywords
- non-invasive diagnosis, melanoma, atypical moles, dysplastic nevi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Blokhin's Russian Cancer Research Center
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 20 Apr 2020 (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.
This is a multicenter, ambispective, low-interventional clinical study evaluating molecular genetic markers for non-invasive differential diagnosis of benign and malignant pigmented skin and mucosal neoplasms. In retrospective cohorts genetics markers will be identified. In prospective cohort non-invasive adhesive system will be tested to identify malignant or benign lesions with prespecified sensitivity and specificity compared to other non-invasive techniques (i.e. dermoscopy) and using histopathological examination as a "golden standard".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Ambispective study with two retrospective cohorts and one prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (retrospective) | No intervention | –Only data from medical records and formalin-fixed paraffin-embedded tissue blocks will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio |
| Cohort 2 (retrospective) | No intervention | –Only data from medical records, formalin-fixed paraffin-embedded tissue blocks and cytologic slides will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio |
| Cohort 3 (prospective) | Other | Procedure: Non-invasive adhesive system (patch)Patients with pigmented lesions on the skin or mucosa who are referred for excisional biopsy will be offered to apply investigated non-invasive adhesive system on their lesion just before the excisional biopsy. After biopsy cytological slides and FFPE tissue blocks will be prepared. All three types of obtained samples will be investigated separately (adhesive patches, cytologic slides and FFPE tissue blocks) for genetic markers whereas cytologic slides and FFPE tissue blocks will be processed also routinely and regular cytologic and histopathologic report will be generated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed diagnosis of melanocytic neoplasm of the skin or mucous membranes (benign, malignant or with unclear potential);
- The presence of a paraffin block with a tumor suitable for molecular genetic analysis;
- Signed informed consent form for living patients (for deceased, signing of a consent form with legal representatives is not required);
- Patient's age is over 18 years for the period of inclusion in the study (at the time of signing the consent form for living patients or for the excision biopsy period for deceased patients);
- Known clinical data of the patient (gender, age, skin phototype), hereditary history, medical history and follow-up of treatment outcomes for at least 5 years
Key exclusion criteria (21 listed)
- Unknown histological diagnosis (no information on the melanocytic nature of the neoplasm)
- Unsuitable for analysis paraffin block with a tumor or its absence
- Unknown history or lack of traceability after diagnosis within 5 years
- For the period of inclusion in the study (signing an informed consent form for living patients or an excision biopsy for deceased patients), the patient's age is under 18 years
- Unknown histological diagnosis (no information on the melanocytic nature of the neoplasm)
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 |
|---|---|---|
| Non-invasive adhesive system (patch)The already registered on the market adhesive skin patch will be applied and removed for several times on the pigmented skin (or mucosal) lesion just before the preplanned excisional biopsy after local anaesthesia have been already administered. Excisional biopsy and local anaesthesia are not the part of this study and will be carried out according to local practice | Procedure or surgery | Cohort 3 (prospective) |
Primary outcome
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination
Time frame: April 2020 - Nov 2022
•Assessment of the sensitivity and specificity of a complex of molecular genetic studies applicable for non-invasive differential diagnosis of benign and malignant melanocytic neoplasms of the skin and mucous membranes in comparison with a standard histological examination
3 secondary outcomes
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to other non-invasive diagnostic tools (i.e. dermoscopy)
Time frame: up to 12 months
Describe some parameters of the identified malignant tumors
Time frame: up to 12 months
Describe the frequency of relapse (local, regional and systemic) within the observation period
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Igor V Samoylenko, MD, PhD principal investigator
N.N. Blokhin Russian Cancer Research Center of Russian MoH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive adhesive system (patch) in people with Melanoma and Melanoma (Skin), run by Russian Academy of Medical Sciences 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 17 inclusion and 21 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 14 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 Igor V Samoylenko, MD, PhD (+7 (909) 972-93-84, i.samoylenko@ronc.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity on the investigated non-invasive genetic method for diffrential diagnosis of benign and malignant melanocytic lesions compared to histopathological examination (time frame: April 2020 - Nov 2022). 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 14 Jun 2022.