Melanoma (Skin Cancer)Precis-mel 2NCT06605443
Precision Medicine for L/GCMN and Melanoma 2
An observational study of Melanoma (Skin Cancer) and Nevi and Melanomas, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
Trial summary
The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer), Nevi and Melanomas, Congenital Melanocytic Nevus
- What is being tested?
- Breath analyzer, Skin patch and Liquid biopsy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2025to 1 Dec 2026
- 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: Adult population (over 18 years of age) diagnosed with melanoma that are currently being treated at the Hospital Clinic de Barcelona or that are admitted before or at the time of the enrolment in the study.
Who may be able to join
- Be over 18 years old
- Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)
Who cannot join
- Not signing the informed consent form
- Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Adrián López Canosa, PhD contact
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Clínic de Barcelona (Dermatology service)
Barcelona, 08036
Susana Puig Sardà, PhD, MD, spuig@clinic.cat
- Recruiting
Hospital Clínic Barcelona
Barcelona
Susana Puig Sardà, MD, PhD, +34932275400, spuig@clinic.cat
Adrián López Canosa, PhD, lopez64@recerca.clinic.cat
- Recruiting
Hospital Clínic Barcelona
Barcelona
Susana Puig Sardà, MD, PhD, +34932275400, spuig@clinic.cat
About this study
Official title: Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)
The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.
Read the detailed description
This is a unicentric national prospective observational study aimed at evaluating the use of two devices (skin patch and breath analyzer) for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months. The study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis. The results will be compared with the standard procedures for the detection of metastatic melanoma (standard imaging techniques such as PET, MRI, etc.) and correlated with standard prognostic biomarkers (cfDNA mutations in BRAF, NRAS, etc.) obtained using liquid biopsy.
- Being tested
- Breath analyzer, Skin patch, Liquid biopsy
- Keywords
- Volatilomics, Breath analyzer, Skin patch, Melanoma, L/GCMN, Liquid biopsy, cfDNA, Non-invasive diagnostics
- Medical subject headings
- Melanoma, Nevi and Melanomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath analyzerDevice
The study subject will be advised to sit quietly for minimum 10 minutes prior the sampling to avoid temporal changes in levels of volatile organic compunds (VOCs) related to body movement or try to avoid abrupt changes in body posture. Then, he/she will be asked to blow in the breath analyzer in order to obtain the exhaled VOCs profile.
Skin patchDevice
A skin patch will be placed in the anterior part of the patient's arm for the obtention of the skin VOCs profile (estimated sampling time of around 1 h). These profiles will be recorded with a dedicated software and analyzed using standard statistical methods.
Liquid biopsyGenetic
Circulating free tumor DNA (cfDNA) will be extracted from patient's blood and analyzed to detect mutations in BRAF and other prognostic genes.
| Study group | Role | What they receive |
|---|---|---|
| Melanoma (non-metastatic) | Patients of either sex over 18 years old with histopathological confirmed melanoma in a non metastatic stage (I to IIb stages according to AJCC classification) Receives: Device: Breath analyzer; Device: Skin patch; Genetic: Liquid biopsy | |
| Melanoma (metastatic) | Patients of either sex over 18 years old with histopathological confirmed melanoma in a metastatic stage (IIIa to IV stages according to AJCC classification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early identification of metastases
The primary objective of the study is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases.
Measured: 24 months
Secondary outcomes (1)
Follow-up of high-risk melanoma patients
The secondary objective is to evaluate the possibility to follow-up high risk melanoma patients using minimally invasive technologies based on the detection of changes in the patterns of volatile organic compounds (VOCs).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605443
- Sponsor's protocol ID
- HCB/2023/1111
- Other IDs
- HORIZON-MISS-2021-CANCER-02-03
- Acronym
- Precis-mel 2
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)
- ClinicalTrials.gov ID
- NCT06605443
- Acronym / sponsor ID
- Precis-mel 2 / HCB/2023/1111
- Keywords
- Volatilomics, Breath analyzer, Skin patch, Melanoma, L/GCMN, Liquid biopsy, cfDNA, Non-invasive diagnostics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Sep 2024 (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.
The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.
Detailed description
This is a unicentric national prospective observational study aimed at evaluating the use of two devices (skin patch and breath analyzer) for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months. The study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis. The results will be compared with the standard procedures for the detection of metastatic melanoma (standard imaging techniques such as PET, MRI, etc.) and correlated with standard prognostic biomarkers (cfDNA mutations in BRAF, NRAS, etc.) obtained using liquid biopsy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melanoma (non-metastatic) | – | Device: Breath analyzer, Device: Skin patch, Genetic: Liquid biopsyPatients of either sex over 18 years old with histopathological confirmed melanoma in a non metastatic stage (I to IIb stages according to AJCC classification) |
| Melanoma (metastatic) | – | –Patients of either sex over 18 years old with histopathological confirmed melanoma in a metastatic stage (IIIa to IV stages according to AJCC classification) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population (over 18 years of age) diagnosed with melanoma that are currently being treated at the Hospital Clinic de Barcelona or that are admitted before or at the time of the enrolment in the study.
Key inclusion criteria (2 listed)
- Be over 18 years old
- Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)
Key exclusion criteria (2 listed)
- Not signing the informed consent form
- Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles
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 |
|---|---|---|
| Breath analyzerThe study subject will be advised to sit quietly for minimum 10 minutes prior the sampling to avoid temporal changes in levels of volatile organic compunds (VOCs) related to body movement or try to avoid abrupt changes in body posture. Then, he/she will be asked to blow in the breath analyzer in order to obtain the exhaled VOCs profile. | Device | Melanoma (non-metastatic) |
| Skin patchA skin patch will be placed in the anterior part of the patient's arm for the obtention of the skin VOCs profile (estimated sampling time of around 1 h). These profiles will be recorded with a dedicated software and analyzed using standard statistical methods. | Device | Melanoma (non-metastatic) |
| Liquid biopsyCirculating free tumor DNA (cfDNA) will be extracted from patient's blood and analyzed to detect mutations in BRAF and other prognostic genes. | Genetic | Melanoma (non-metastatic) |
Primary outcome
Early identification of metastases
Time frame: 24 months
The primary objective of the study is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases.
1 secondary outcome
Follow-up of high-risk melanoma patients
Time frame: 24 months
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 27 Feb 2025.
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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.
Adrián López Canosa, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin Cancer) and Nevi and Melanomas, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
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 2 inclusion and 2 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 Susana Puig Sardà, PhD, MD (+34932275400, spuig@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early identification of metastases (time frame: 24 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 27 Feb 2025.