Actively Recruiting
Clinical Study to Evaluate Rarecells ISET4 Circulating Tumor Cell DNA and Circulating Tumor DNA for Early Detection of Lung Cancer
Led by Rarecells Diagnostics SAS · Updated on 2025-06-11
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
R
Rarecells Diagnostics SAS
Lead Sponsor
M
Meditrial Europe Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Early diagnosis of lung cancer is essential for improving health outcomes and managing the disease effectively. This research evaluates the accuracy of two molecular biomarkers found in the blood—Rarecells ISET® circulating tumor cell DNA (CTC-DNA) and circulating tumor DNA (ctDNA)—for the early detection of lung cancer. These biomarkers could provide a non-invasive and risk-free method to identify lung cancer and monitor for recurrences after treatment. Participants diagnosed with operable lung cancer who are planned for lung resection with curative intent will be included. Upon enrollment, patients will undergo assessments including a low-dose CT scan, isolation of circulating tumor cells using the sensitive ISET® method, and plasma separation for ctDNA analysis. This observational study focuses on comparing the sensitivity of these two liquid biopsy biomarkers in detecting lung cancer. Throughout the study, researchers will measure the complementary sensitivity of CTC-DNA and ctDNA approximately 30 days after the surgical procedure. Participants will be monitored through molecular analyses of blood samples and imaging to assess the biomarkers’ accuracy. The study is sponsored by Rarecells Diagnostics SAS and is expected to end in October 2025.
CONDITIONS
Brief Title
Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 35 and 85 years
- Diagnosed with resectable lung cancer not yet treated
- Able to give free, informed, and express consent
- No detectable extra thoracic or distant metastases
- Evaluation of operative risk and tumor type as applicable
You will not qualify if you...
- Previous diagnosis or treatment for lung cancer or any other cancer
- Treated with neoadjuvant therapy
- Pregnant women
- Psychiatric or neurological disorders preventing understanding of the research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo low-dose CT scan, isolation of circulating tumor cells by the ISET® method, and separation of plasma for analysis of circulating tumor DNA.
1 visit (in-person)
Duration - 30 days post procedure
Participants with operable lung cancer planned for resection are observed to assess molecular biomarkers in blood before and after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Università Cattolica del Sacro Cuore Gemelli Hospital
Roma, Italy
Actively Recruiting
Research Team
M
Monica Tocchi, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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