Precision Medicine for L/GCMN and Melanoma 2

NCT06605443 | Recruiting

• 2 other identifiers: HCB/2023/1111HORIZON-MISS-2021-CANCER-02-03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.

Conditions

Melanoma (Skin Cancer); Nevi and Melanomas; Congenital Melanocytic Nevus

Keywords

Volatilomics; Breath analyzer; Skin patch; Melanoma; L/GCMN; Liquid biopsy; cfDNA; Non-invasive diagnostics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Follow-up of high-risk melanoma patients

  24 months

Study Arms (2)

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)

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)

Interventions

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.

Melanoma (non-metastatic)

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.

Melanoma (non-metastatic)

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.

Melanoma (non-metastatic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (3)

Hospital Clínic de Barcelona (Dermatology service)

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital Clínic Barcelona

Barcelona, Spain

RECRUITING

Hospital Clínic Barcelona

Barcelona, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cell-free DNA will be extracted from patient blood and saliva.

MeSH Terms

Conditions

Melanoma; Nevi and Melanomas

Interventions

Transdermal Patch; Liquid Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Susana Puig Sardà, PhD, MD

CONTACT

+34932275400; spuig@clinic.cat

Adrián López Canosa, PhD

CONTACT

lopez64@recerca.clinic.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2024-09

Locations

ES (3)