Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-01-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
Breath analyzer
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 patch
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 biopsy
Circulating free tumor DNA (cfDNA) will be extracted from patient's blood and analyzed to detect mutations in BRAF and other prognostic genes.
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)
No interventions assigned to this group
Interventions
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Breath analyzer
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 patch
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 biopsy
Circulating free tumor DNA (cfDNA) will be extracted from patient's blood and analyzed to detect mutations in BRAF and other prognostic genes.
Eligibility Criteria
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Inclusion Criteria
* Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)
Exclusion Criteria
* Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Locations
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Hospital Clínic de Barcelona (Dermatology service)
Barcelona, , Spain
Hospital Clínic Barcelona
Barcelona, , Spain
Hospital Clínic Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HORIZON-MISS-2021-CANCER-02-03
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HCB/2023/1111
Identifier Type: -
Identifier Source: org_study_id
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