MelanomaMELODINCT07883954
Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
An observational study of Melanoma, run by Mitra Bio at 5 sites in 4 countries.
Trial summary
Background and Study Aims: Melanoma is the most dangerous form of skin cancer, and early detection is crucial for improving patient outcomes. Over 90% of suspected skin cancer lesions are not melanoma, leading to a significant proportion of patients undergoing invasive skin biopsies for non-relevant lesions (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 2,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 10 Jun 2026to 15 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults undergoing a standard of care biopsy of a suspicious skin lesion
Who may be able to join
- At least 18 years of age
- Undergoing a standard of care biopsy or excision procedure for a pigmented lesion that is suspected of being a melanoma
- Willing and able to sign informed consent
- Willing to undergo a non-invasive skin tape sample collection procedure prior to standard of care biopsy/excision (up to 1 week prior to or on the day of the biopsy/excision procedure)
- Able to complete both the tape collection and biopsy/excision procedures
Who cannot join
- Individuals with significant skin disease that is outside the scope of the diseases which will be investigated
- Individuals who have other skin complications at the lesion site Suspicious pigmented lesion is located on the palms, soles of feet, or a highly hair-dense anatomical site (e.g., scalp, beard area)
- Individuals with learning difficulties, severely ill patients, and other vulnerable groups (e.g., mental illness, dementia)
- Individuals outside the defined age group
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) within the previous 8 weeks.
- Individuals with an allergy that may interfere with the procedure.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Kirsten Tuck contact
5 sites in 4 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Free Hospital
London
Rachel Odiel, +44 020 7317 7558, rf-tr.randd@nhs.net
Kathy TAGHIPOUR
- Recruiting
Whittington Hospital
London
Leanne Taylor, +44 020 7288 3585, whh-tr.researchsupport@nhs.net
Kathy Taghipour
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent
Isabel De Vuysdere, +32 9 332 0577, isabel.devuysdere@uzgent.be
Lieve Brochez
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen
Paula Jofré, +49 7071 29-0, Paula.Pacheco@med.uni-tuebingen.de
Ulrike Leiter-Stöppke
Spain1 site, 1 recruiting
- Not yet recruiting
IDIBAPS
Barcelona
Pablo García, RN, +34 93 227 54 00 ext. ext. 4840-4622, piglesia@recerca.clinic.cat
Josep Malvehy
About this study
Background and Study Aims:
Melanoma is the most dangerous form of skin cancer, and early detection is crucial for improving patient outcomes. Over 90% of suspected skin cancer lesions are not melanoma, leading to a significant proportion of patients undergoing invasive skin biopsies for non-relevant lesions (1). Mitra Bio has developed a novel, non-invasive skin-tape test that captures skin cells from pigmented lesions that are suspected of being melanoma and detects the presence of melanoma-specific methylation biomarkers.
Read more
The goal of this study is to further develop and to prospectively clinically validate Mitra Bio's methylation biomarkers and algorithm, applied to skin samples collected non-invasively using skin-tapes, for the detection of melanoma.
Who can participate?
We will invite people from participating hospitals who:
-are scheduled for a standard of care biopsy of a suspicious lesion What does the study involve? All participants will have a one-time visit prior to their standard of care biopsy appointment. This visit will include clinical data collection, tape sample collection, and a participant survey.
Discovery Cohort: Involves using a tape sample collection method on the suspicious lesion, healthy contralateral skin, and the forehead.
Validation Cohort: Involves using tape sample collection method on only the suspicious lesion.
The participant's active role in the study concludes after this one visit. The research team will collect and review pathology data from the standard of care biopsy.
What are the risks and benefits of participating? This study could help improve non-invasive diagnostics for melanoma, significantly reducing the number of unnecessary biopsies. By taking part, you make that possible.
The tape sample collection is not painful and most people have no reaction. Mild and temporary skin redness and discomfort at the sampling site are the most common complaints.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Discovery Cohort | To identify and optimise a panel of methylation biomarkers from non-invasively collected skin-tape samples that can distinguish melanoma from non-melanoma skin lesions. | |
| Validation Cohort | To prospectively evaluate the diagnostic performance (sensitivity and specificity) of the finalised methylation biomarker panel and associated algorithm for the detection of melanoma, as applied to skin-tape samples from patients routinely referred for biopsy or excision of a suspected melanoma, compared against biopsy and histology as the diagnostic reference standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Discovery Outcome
Identification and optimisation of methylation biomarkers capable of distinguishing melanoma from non-melanoma lesions.
Differential methylation effect sizes and statistical significance (CpG sites and regions).
Measured: 6 Months
Primary Validation Outcome
Performance of biomarkers in differentiating melanoma from non-melanoma samples in the study population: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), each with 95% CIs.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start10 Jun 2026
- Primary completion10 Oct 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Innovation Council
- Responsible party
- Sponsor
- Investigators
- Josep Malvehy, MD, Principal investigator, Institut d'Investigacions Biomèdiques August Pi i SunyerLieve Brochez, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883954
- Sponsor's protocol ID
- 101247537
- Acronym
- MELODI
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Banila C, Kaveh S, Green D 1612 Non-invasive method for comprehensive skin whole genome methylome mapping Journal of Investigative Dermatology, 143S276
Banila C, Green D, Katsanos D, Viana J, Osmaston A, Menendez Vazquez A, Lynch M, Kaveh S. A noninvasive method for whole-genome skin methylome profiling. Br J Dermatol. 2023 Nov 16;189(6):750-759. doi: 10.1093/bjd/ljad316.
PubMed 37658851Menendez Vazquez A, Katsanos D, Vasile M, Graham A, Dyster V, Kaveh S, Moqri M, Banila C. Epigenetic age predictors for non-invasive assessment of human skin. NPJ Aging. 2025 Dec 12;12(1):11. doi: 10.1038/s41514-025-00314-0.
PubMed 41387742
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Multi-Centre Validation of a Novel Non-Invasive Melanoma Molecular Diagnostic Test
- ClinicalTrials.gov ID
- NCT07883954
- Acronym / sponsor ID
- MELODI / 101247537
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mitra BioIndustry (pharma, biotech, devices)
- Collaborators
- European Innovation Council
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
Background and Study Aims:
Melanoma is the most dangerous form of skin cancer, and early detection is crucial for improving patient outcomes. Over 90% of suspected skin cancer lesions are not melanoma, leading to a significant proportion of patients undergoing invasive skin biopsies for non-relevant lesions (1). Mitra Bio has developed a novel, non-invasive skin-tape test that captures skin cells from pigmented lesions that are suspected of being melanoma and detects the presence of melanoma-specific methylation biomarkers.
The goal of this study is to further develop and to prospectively clinically validate Mitra Bio's methylation biomarkers and algorithm, applied to skin samples collected non-invasively using skin-tapes, for the detection of melanoma.
Who can participate?
We will invite people from participating hospitals who:
-are scheduled for a standard of care biopsy of a suspicious lesion What does the study involve? All participants will have a one-time visit prior to their standard of care biopsy appointment. This visit will include clinical data collection, tape sample collection, and a participant survey.
Discovery Cohort: Involves using a tape sample collection method on the suspicious lesion, healthy contralateral skin, and the forehead.
Validation Cohort: Involves using tape sample collection method on only the suspicious lesion.
The participant's active role in the study concludes after this one visit. The research team will collect and review pathology data from the standard of care biopsy.
What are the risks and benefits of participating? This study could help improve non-invasive diagnostics for melanoma, significantly reducing the number of unnecessary biopsies. By taking part, you make that possible.
The tape sample collection is not painful and most people have no reaction. Mild and temporary skin redness and discomfort at the sampling site are the most common complaints.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discovery Cohort | – | –To identify and optimise a panel of methylation biomarkers from non-invasively collected skin-tape samples that can distinguish melanoma from non-melanoma skin lesions. |
| Validation Cohort | – | –To prospectively evaluate the diagnostic performance (sensitivity and specificity) of the finalised methylation biomarker panel and associated algorithm for the detection of melanoma, as applied to skin-tape samples from patients routinely referred for biopsy or excision of a suspected melanoma, compared against biopsy and histology as the diagnostic reference standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing a standard of care biopsy of a suspicious skin lesion
Key inclusion criteria (5 listed)
- At least 18 years of age
- Undergoing a standard of care biopsy or excision procedure for a pigmented lesion that is suspected of being a melanoma
- Willing and able to sign informed consent
- Willing to undergo a non-invasive skin tape sample collection procedure prior to standard of care biopsy/excision (up to 1 week prior to or on the day of the biopsy/excision procedure)
- Able to complete both the tape collection and biopsy/excision procedures
Key exclusion criteria (6 listed)
- Individuals with significant skin disease that is outside the scope of the diseases which will be investigated
- Individuals who have other skin complications at the lesion site Suspicious pigmented lesion is located on the palms, soles of feet, or a highly hair-dense anatomical site (e.g., scalp, beard area)
- Individuals with learning difficulties, severely ill patients, and other vulnerable groups (e.g., mental illness, dementia)
- Individuals outside the defined age group
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) within the previous 8 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Discovery Outcome
Time frame: 6 Months
Identification and optimisation of methylation biomarkers capable of distinguishing melanoma from non-melanoma lesions. Differential methylation effect sizes and statistical significance (CpG sites and regions).
Primary Validation Outcome
Time frame: 6 Months
Performance of biomarkers in differentiating melanoma from non-melanoma samples in the study population: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), each with 95% CIs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- BackgroundBanila C, Kaveh S, Green D 1612 Non-invasive method for comprehensive skin whole genome methylome mapping Journal of Investigative Dermatology, 143S276
- Background: PubMed 37658851Banila C, Green D, Katsanos D, Viana J, Osmaston A, Menendez Vazquez A, Lynch M, Kaveh S. A noninvasive method for whole-genome skin methylome profiling. Br J Dermatol. 2023 Nov 16;189(6):750-759. doi: 10.1093/bjd/ljad316.
- Background: PubMed 41387742Menendez Vazquez A, Katsanos D, Vasile M, Graham A, Dyster V, Kaveh S, Moqri M, Banila C. Epigenetic age predictors for non-invasive assessment of human skin. NPJ Aging. 2025 Dec 12;12(1):11. doi: 10.1038/s41514-025-00314-0.
- Mitrabio company websiteLink provided by the sponsor.
- 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.
Kirsten Tuck contact
Josep Malvehy, MD principal investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Lieve Brochez, MD principal investigator
University Hospital, Ghent
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Mitra Bio at 5 sites in 4 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Belgium, Germany, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Juniat (734-358-9550, stephanie@mitrabio.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Discovery Outcome (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07883954, which also lists 3 linked publications.
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 21 Oct 2026.