Precision Medicine for L/GCMN and Melanoma 2

NCT ID: NCT06605443

Last Updated: 2025-02-27

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma (Skin Cancer) Nevi and Melanomas Congenital Melanocytic Nevus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type 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

Intervention Type 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

Intervention Type GENETIC

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Be over 18 years old
* Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clínic de Barcelona (Dermatology service)

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clínic Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Clínic Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Susana Puig Sardà, PhD, MD

Role: CONTACT

+34932275400

Adrián López Canosa, PhD

Role: CONTACT

Facility Contacts

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Susana Puig Sardà, PhD, MD

Role: primary

Susana Puig Sardà, MD, PhD

Role: primary

+34932275400

Adrián López Canosa, PhD

Role: backup

Susana Puig Sardà, MD, PhD

Role: primary

+34932275400

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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