Personalized risk assessment for lung cancer surgery
Validation of Predictive Model in Value-based Medicine for Lung Cancer and Analysis of Its Implications for Patient Communication
This study is testing a way to create personalized risk profiles for patients with non-small cell lung cancer to see how surgery might affect their quality of life and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06703866 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate predictive models for patients diagnosed with non-small cell lung cancer who are eligible for surgical lung resection. Participants will complete quality of life questionnaires before surgery and at multiple intervals post-discharge to gather data on surgical complications, pain, fatigue, dyspnea, and overall well-being. The collected information will help develop personalized clinical-functional risk profiles to estimate the likelihood of various outcomes after surgery. This approach seeks to enhance patient care by providing tailored risk assessments prior to surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of non-small cell lung carcinoma who are eligible for surgical lung resection.
Not a fit: Patients with benign lesions or those who have previously undergone lung surgery for recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pre-surgical risk assessments, allowing for better patient management and outcomes.
How similar studies have performed: Other studies have shown promise in using predictive models for surgical outcomes, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 18 years * Patients with diagnosis of non-small cell lung carcinoma * Only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy * Diagnosis of primary non-small cell lung cancer * Signed Informed Consent * Patients must be available for follow-up Exclusion Criteria: * Patients with benign lesion * Patients with recurrence who have already undergone lung surgery * Conditions/pathologies that prevent the ability to give consent
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Monica Casiraghi — European Institute of Oncology
- Study coordinator: Monica Casiraghi
- Email: monica.casiraghi@ieo.it
- Phone: +39 02 57489425
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.