New method for detecting melanoma biomarkers in blood samples
Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
This study is testing a new blood test that looks for specific markers of melanoma to see if it works better than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05940311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed cutaneous melanoma and the BRAF p.V600E mutation, who are eligible for specific targeted therapies.
Not a fit: Patients with a life expectancy of less than 8 weeks or those unable to comply with blood drawing requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and sensitive detection of melanoma biomarkers, improving patient management and treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in the detection of biomarkers using liquid biopsy techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome
- "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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.