Tracking how lung cancer cells spread after surgery
Insights on Dissemination of Lung Cancer
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07476495
This project will see if blood tests for circulating tumor cells and tumor DNA, together with tumor tissue analysis, can predict recurrence in people having surgery for early-stage non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07476495 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with resectable clinical stage IA–IIIA non-small cell lung cancer (adenocarcinoma or squamous) who undergo surgery alone or as part of multimodal treatment. Researchers will count circulating tumor cells (CTCs) using the CellSearch platform and analyze circulating tumor DNA (ctDNA) with Illumina-based next-generation sequencing from blood taken before surgery, after surgery, and during follow-up. They will compare molecular profiles using spatial transcriptomics between primary tumor cells, tumor cells in spread through air spaces (STAS), lymph node micrometastases, and circulating tumor cells, and will examine whether intraoperative factors (resection sequence, surgical approach, extent of resection) affect release of tumor material into the blood. The goal is to link these measures to recurrence patterns and long-term outcomes to improve risk stratification.
Who should consider this trial
Good fit: Adults (≥18) with resectable clinical stage IA–IIIA non-small cell lung cancer of adenocarcinoma or squamous histology who are planned for surgical treatment, with or without additional therapies, are ideal candidates.
Not a fit: Patients with other histologies, those with metastatic disease, those not undergoing surgery, or anyone treated with systemic cancer therapy within the previous three years are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk of recurrence so follow-up and treatment can be better personalized.
How similar studies have performed: Prior research has shown CTCs and ctDNA can indicate recurrence risk after lung cancer surgery, but combining these blood markers with spatial transcriptomics and detailed intraoperative analysis is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Preoperative diagnosis of resectable stage cIA-cIIIA NSCLC (adenocarcinoma or squamous cell carcinoma); * Patients deemed fit for surgical or multimodal treatment; * Informed consent obtained; * Treatment, including multimodal treatment, involving surgery. Exclusion Criteria: * Histology other than adenocarcinoma or squamous cell carcinoma; * Other neoplastic diseases concurrent with or undergoing treatment or treated with systemic therapies in the previous three years; * Age \<18 years; * No need for surgery.
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Università di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Pietro Bertoglio
- Email: pietro.bertoglio@aosp.bo.it
- Phone: +39 0516478362
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.
Conditions: Oncology & Epidemiology & Lung Cancer