Precision Medicine for L/GCMN and Melanoma 2 (Precis-mel 2)

February 25, 2025 updated by: Fundacion Clinic per a la Recerca Biomédica

Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Susana Puig Sardà, PhD, MD
  • Phone Number: +34932275400
  • Email: spuig@clinic.cat

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
          • Susana Puig Sardà, MD, PhD
          • Phone Number: +34932275400
          • Email: spuig@clinic.cat
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clínic de Barcelona (Dermatology service)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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.
Genetic: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early identification of metastases
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up of high-risk melanoma patients
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Collaborators

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2023/1111
  • HORIZON-MISS-2021-CANCER-02-03 (Other Grant/Funding Number: European Comission)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nevi and Melanomas

Clinical Trials on Breath analyzer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe