Rarecells blood test combining circulating tumor cell DNA and circulating tumor DNA for early lung cancer detection
Official title: Clinical Study To Evaluate the Sensitivity of Circulating Iset® by Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
Run by Rarecells Diagnostics SAS · NCT06546007 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 35 Years to 85 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Rarecells Diagnostics SAS Industry-sponsored |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | November 13, 2024 |
| Main results expected | June 1, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT06546007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Innovative care program for lung cancer survivors
This study is testing a new care program designed to help lung cancer survivors in Kentucky feel better and improve their quality of life compared to standard care.
-
ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden
This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.
-
Urine VOC Test to Detect Lung Cancer in Never Smokers
A urine test that looks for volatile compounds is tested to see if it can help detect lung cancer in adults who have never smoked.
-
SI-B036 safety test in advanced and metastatic solid tumors
This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.
-
Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment
This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.
-
ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients
This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.