Rarecells blood test combining circulating tumor cell DNA and circulating tumor DNA for early lung cancer detection
Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
This test checks whether combining Rarecells ISET® circulating tumor cell DNA and circulating tumor DNA from a blood sample can find early or returning lung cancer in people with operable tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Rarecells Diagnostics SAS Industry-sponsored |
| Locations | 1 site (Roma) |
| Trial ID | NCT06546007 on ClinicalTrials.gov |
What this trial studies
This is an observational diagnostic study enrolling adults with newly diagnosed, resectable lung cancer who have not yet received treatment. Participants undergo a low-dose CT, blood draws for isolation of circulating tumor cells using the ISET® method, and plasma collection for circulating tumor DNA analysis. Molecular results from CTC-DNA and ctDNA will be compared with tissue pathology from biopsy or surgical resection to determine sensitivity for detecting primary tumors and early recurrence. Key exclusions include prior cancer treatment, neoadjuvant therapy, pregnancy, and inability to give informed consent.
Who should consider this trial
Good fit: Adults aged 35–85 with a new diagnosis of resectable lung cancer who have not yet been treated and who can give informed consent are the ideal candidates.
Not a fit: Patients previously treated for lung or other cancers, those who received neoadjuvant therapy, pregnant women, and people unable to consent are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, this approach could enable earlier and less invasive detection of lung cancer and earlier identification of recurrence, allowing timelier treatment.
How similar studies have performed: Circulating tumor DNA assays have shown promise for detecting recurrence and actionable mutations in lung cancer, while CTC-DNA isolated by ISET® is less established and the combined approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged between 35 and 85 years 2. Patient diagnosed with resectable lung cancer (by imaging and/or pathological examination) not yet treated for this cancer. 3. Patient capable of giving free, informed, and express consent The assessment of successful elected surgery implies, but is not limited to, the following: * Exclusion of detectable extra thoracic and distant metastases * Determination of the presence or absence of superior mediastinal lymph node metastases * Definition of the histologic or cell type, whenever possible * Evaluation of operative risk Exclusion Criteria: 1. Patient diagnosed and/or treated previously for lung cancer or another cancer, regardless of duration 2. Patient treated with neoadjuvant treatment 3. Pregnant women 4. Patient presenting psychiatric or neurological disorders preventing them from understanding the research
Where this trial is running
Roma
- Università Cattolica del Sacro Cuore Gemelli Hospital — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Monica Tocchi, MD, PhD
- Email: m.tocchi@meditrial.net
- Phone: 6469331025
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.