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| ID | Type | Description | Link |
|---|---|---|---|
| HORIZON-MISS-2021-CANCER-02-03 | Other Grant/Funding Number | European Comission |
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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath analyzer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susana Puig Sardà, PhD, MD | Contact | +34932275400 | spuig@clinic.cat | |
| Adrián López Canosa, PhD | Contact | lopez64@recerca.clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona (Dermatology service) | Not yet recruiting | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018326 | Nevi and Melanomas |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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Cell-free DNA will be extracted from patient blood and saliva.
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| Skin patch | Device | 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. |
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| Liquid biopsy | Genetic | Circulating free tumor DNA (cfDNA) will be extracted from patient's blood and analyzed to detect mutations in BRAF and other prognostic genes. |
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| Hospital Clínic Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Clínic Barcelona | Recruiting | Barcelona | Spain |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |