New method for detecting melanoma biomarkers in blood samples

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational trial aims to evaluate a novel in vitro diagnostic device designed for liquid biopsy, which allows for the simultaneous detection of protein and nucleic acid analytes at a single-molecule sensitivity level. The study will utilize a unique affinity-mediated transport amplification method to quantify rare biomarkers in blood, specifically targeting the BRAF p.V600E mutation and a melanoma-specific protein antigen. Results from this device will be compared to traditional methods such as digital PCR and ELISA to assess its effectiveness and accuracy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age: ≥ 18
* PFS≤2
* Patients willing to sign an informed consent;
* Confirmed (cytologically or histologically) cutaneous melanoma diagnosis
* Confirmed BRAF p. V600E tumor status
* Eligible for BRAFi/MEKi treatment or Immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages III/IV, high risk).

Exclusion Criteria:

* Life expectancy \<8 weeks
* Other clinical conditions preventing blood drawing compliance, as per physician's choice.

Where it's running

• "Regina Elena" National Cancer Institute
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Elena Giordani, PhD
• Email: elena.giordani@ifo.it
• Phone: +39 06 5266 2533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.