Examining circulating tumor cells in lung cancer patients during surgery with and without heart-lung support
Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB)
European Institute of Oncology · NCT04048512
This study is testing if using heart-lung support during lung cancer surgery affects the number of tumor cells in the blood of patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT04048512 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the presence and quantity of circulating tumor cells (CTC) in patients undergoing lung and mediastinal resections. It compares patients who receive intraoperative cardiorespiratory support via ECMO or CPB with those who do not, focusing on the potential impact of these supports on tumor cell spread. The study will assess blood samples taken before and after surgery to quantify CTC levels, contributing to the understanding of surgical risks in lung cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with locally advanced lung or mediastinal cancers requiring surgical resection and intraoperative support.
Not a fit: Patients who are younger than 18, have contraindications to general anesthesia, or poor clinical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of using ECMO or CPB during lung cancer surgeries, potentially improving surgical outcomes.
How similar studies have performed: While the theoretical risks of metastasis due to ECMO or CPB have been discussed, there is a lack of clear clinical evidence, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thoracic resection (lung and or mediastinal resection) requiring intraoperative Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) support; in the control group same disease and planned procedure to be performed without the need of EMCO or CPB. * Infiltration of the main carina * Infiltration of superior vena cava * Single lung surgery * Mediastinal involvment Exclusion Criteria: * Age younger than 18 years * Contraindications to general anesthesia * Poor general clinical conditions ( ECOG PS \>=2) * Patients unable to provide informed consent
Where this trial is running
Milan
- European Institue of Oncology — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Francesco Petrella — European Institute of Oncology
- Study coordinator: Francesco Petrella, MD, PhD
- Email: francesco.petrella@ieo.it
- Phone: 00393388231311
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: Thoracic Surgery, Cardiopulmonary Bypass