Non-small Cell Lung Cancer, NSCLC, NSCLC, Stage I, NSCLC, Stage III
Conditions
Keywords
NSCLC early stage, NSCLC locally advanced, retrospective observational study, Real-World Evidence
Brief summary
This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).
Detailed description
Due to heterogeneity of patients with stage I-III Non Small Cell Lung Cancer (NSCLC), there is not a unique common therapeutic approach and there is no consensus about the optimal timing, sequencing and combination of surgery, chemotherapy and radiotherapy across the spectrum of early stage and locally advance disease. Consequently, the choice of local treatment modality can vary across countries and centers.
Interventions
None listed
Sponsors
YGHEA, CRO Division of Ecol Studio spa
MSD Italia S.r.l.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021 2. Adult patients (aged ≥ 18 years) at the moment of diagnosis 3. Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient.
Exclusion criteria
1. Patients without availability of medical charts or information required 2. Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NSCLC treatment approaches in Real-World practice | Restrospective data capture from January 2018 to January 2021. | Percentage of patients undergoing to: 1. surgical resection of the lung cancer with curative intent; 2. definitive (chemo)radiotherapy (defined as any regimen of chemotherapy administered with concurrent radiotherapy) 3. neoadjuvant treatment (4 cycles) before surgery 4. adjuvant treatments (4 cycles) after surgery |
| Direct medical costs of different therapeutic approaches | Restrospective data capture from January 2018 to January 2021. | The cost of the therapeutic approach (cost of illness) will be estimated through an activity-based costing (ABC) technique which allows to calculate the full cost of a service by measuring the cost of each individual activity/resource related to it. |
| Healthcare resource utilization aof different therapeutic approaches | Restrospective data capture from January 2018 to January 2021. | Healthcare resources used to manage the patients will be described in terms of lab tests and/or outpatient visits and/or drug therapy and/or diagnostic tests. |
| Percentage of patients discusses in multidisciplinary team | Restrospective data capture from January 2018 to January 2021 | Multidisciplinary team defined as the involvement of radiotherapy unit, pneumology and/or interventional pneumology unit in patient discussion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSCLC treatments timeline in Real-World practice | Restrospective data capture from January 2018 to January 2021. | Median Time from: 1. diagnosis/multidisciplinary referral to surgery or start of radioterapy 2. surgery/completion of Radiotherapy to satrt of adjiuvant treatmen |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers profile evaluation at NSCLC diagnosis | Restrospective data capture from January 2018 to January 2021. | Percentage of PD-L1, EGFR/ALK, KRAS test performed along with results |
| KRAS Biomarkers profile evaluation at NSCLC diagnosis | Restrospective data capture from January 2018 to January 2021. | Percentage of KRAS test performed along with result |
| EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis | Restrospective data capture from January 2018 to January 2021. | Percentage of EGFR/ALK test performed along with results |
| PD-L1 Biomarker profile evaluation at NSCLC diagnosis | Restrospective data capture from January 2018 to January 2021. | Percentage of PD-L1 test performed along with results |
Countries
Italy
Contacts
Primary ContactDaniele Righi, PM
Outcome results
None listed