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Search / Trial NCT05940311

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Launched by REGINA ELENA CANCER INSTITUTE · Jul 3, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Brafv600 E

ClinConnect Summary

This clinical trial, called VerSiLiB, is studying a new way to detect very small amounts of proteins and genetic material in blood samples from patients with a specific type of skin cancer called melanoma, particularly those with a mutation known as BRAF V600E. The goal is to improve how we can find and analyze these important markers to help in managing cancer more effectively. The researchers are testing a unique method that uses tiny magnetic particles and fluorescent signals to identify whether these markers are present in the blood, which could provide more information than current techniques.

To participate in this trial, individuals must be between 65 and 74 years old, have melanoma with the BRAF V600E mutation, and be receiving adjuvant therapy (treatment given after initial therapy to reduce the risk of cancer returning). They also need to provide written consent to take part. Participants will be asked to provide blood samples, and they can expect to contribute to important research that may lead to better cancer detection methods in the future. It's essential to note that individuals with a very short expected overall survival (less than 8 weeks) are not eligible for this study.

Gender

ALL

Eligibility 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.

About Regina Elena Cancer Institute

The Regina Elena Cancer Institute is a leading research and treatment center dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. Located in Rome, Italy, the institute is committed to enhancing cancer treatment methodologies and improving patient outcomes by fostering a collaborative environment among clinicians, researchers, and patients. With a focus on cutting-edge therapies and personalized medicine, the Regina Elena Cancer Institute plays a pivotal role in the global fight against cancer, contributing to significant breakthroughs in cancer research and treatment protocols.

Locations

Rome, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported