Precision Medicine for L/GCMN and Melanoma 2

ConditionsMelanoma (Skin Cancer)Nevi and Melanomas Congenital Melanocytic Nevus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be over 18 years old

Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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.
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.
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Melanoma (non-metastatic)3 interventions

Group B: Melanoma (metastatic)0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

24 months

Secondary outcomes

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).

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Clinic per a la Recerca Biomédica

Lead sponsor

Hospital Clinic of Barcelona

Collaborator

Source ClinicalTrials.gov

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