Clinical trial · Observational
Value-Based Medicine (VBM) for Lung Cancer
Validation of Predictive Model in Value-based Medicine for Lung Cancer and Analysis of Its Implications for Patient Communication
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non Small Cell Lung Cancer (NSCLC)
- description
- Patients with diagnosis of Non Small Cell Lung Cancer (NSCLC) eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy
- interventionNames
- Other: Non Small Cell Lung Cancer (NSCLC)
Primary outcomes (1)
- measure
- Creation of a personalized clinical-functional risk profile
- timeFrame
- 12 months
- description
- Developement of a personalized clinical-functional risk profile for estimating , prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge. The patient will be asked to complete questionnaires (EORTC QLQ-C30 / EORTC QLQ- LC13) on clinical-functional status and quality of life both before and after surgery, at 30 days, 4 months, 8 months and 12 months after discharge. The information acquired with the questionnaires, together with the clinical information acquired during the healthcare services, will be used to validate and refine the predictive models created and will be used to create a personalized clinical-functional risk profile.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available