Trials / Not Yet Recruiting
Not Yet RecruitingNCT07359885
Prediction of Postoperative Pulmonary Complications in Thoracic Surgery
Prediction of Postoperative Pulmonary Complications in Thoracic Surgery: an Immuno-inflammatory Approach
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- University Hospital, Rouen · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Lung cancer is a common disease, and its treatment is lobectomy or pulmonary segmentectomy. In France, approximately 8,000 patients undergo this procedure each year, but it remains associated with significant Postoperative Pulmonary Complications (PPC). This surgical trauma triggers a multicellular and orchestrated immune response, necessary for defense against pathogens, as well as for inflammatory resolution and wound healing. Preoperative single-cell analysis of the patient's immune system is therefore a promising strategy for identifying biomarkers of postoperative pulmonary complications (PPC). Brice Gaudilliere's laboratory at Stanford University, in collaboration with the Paris-based startup Surge, has developed and patented a multivariate model integrating mass cytometry data, proteomic analyses, and clinical data collected before surgery to accurately predict surgical site complications after major abdominal surgery. However, no study has yet explored the identification of inflammatory biomarkers predictive of PPC after thoracic surgery.
Detailed description
The issue of postoperative pulmonary complications following major lung resection (such as lobectomy or segmentectomy) is a central topic in anesthesia and thoracic surgery. Postoperative morbidity and mortality after this type of surgery have drastically decreased in recent years with advances in anesthesia and resuscitation, as well as minimally invasive surgery, but remain high compared to other types of surgery, particularly due to postoperative pneumonia. The etiology of postoperative pneumonia is multifactorial (atelectasis, postoperative ventilation, inadequate analgesia), but the patient's immune system plays a predominant role in each individual case. Therefore, identifying inflammatory biomarkers predictive of postoperative pulmonary complications in a given patient could optimize their management and reduce the risk of postoperative pulmonary cancer (PPC). The objective of this study is to identify preoperative inflammatory biomarkers predictive of PPC after major lung resection. It will use machine learning methods specific to these data to define an immune signature of PPC. This immune signature will be validated using standard analytical techniques to facilitate the clinical translation of a diagnostic test.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Evaluation of prognostic performance of a defined score using a machine learning method (STABL: Stability Selection) integrating immune data (cytometric and proteomic) | Determination of the area under the curve (AUC) Receiver Operating Curve (ROC) for predicting complications calculated from the score obtained by the machine learning method and the occurrence of at least one major pulmonary complication among the following in the first 7 postoperative days: postoperative pneumonia, pleural effusion, postoperative atelectasis, pneumothorax, bronchospasm and acute respiratory distress syndrome. |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-09-01
- Completion
- 2029-03-01
- First posted
- 2026-01-22
- Last updated
- 2026-01-22
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07359885. Inclusion in this directory is not an endorsement.