A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMSD Italia S.r.l.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Adult patients (aged ≥ 18 years) at the moment of diagnosis
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.
Disqualifiers
Patients without availability of medical charts or information required
Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
Trial population
The study population will consist of patients with early stage and locally advanced NSCLC (stage I-III) who had completed curative treatment planning and subsequent at least 18-months follow-up between January 2018 and January 2021.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
NSCLC treatment approaches in Real-World practice
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
Time frame
Restrospective data capture from January 2018 to January 2021.2
Percentage of patients discusses in multidisciplinary team
Multidisciplinary team defined as the involvement of radiotherapy unit, pneumology and/or interventional pneumology unit in patient discussion.
Time frame
Restrospective data capture from January 2018 to January 20213
Healthcare resource utilization aof different therapeutic approaches
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.
Time frame
Restrospective data capture from January 2018 to January 2021.4
Direct medical costs of different therapeutic approaches
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.
Time frame
Restrospective data capture from January 2018 to January 2021.Secondary outcomes
1
NSCLC treatments timeline in Real-World practice
Median Time from: 1. diagnosis/multidisciplinary referral to surgery or start of radioterapy 2. surgery/completion of Radiotherapy to satrt of adjiuvant treatmen
Time frame
Restrospective data capture from January 2018 to January 2021.Other outcomes
1
Biomarkers profile evaluation at NSCLC diagnosis
Percentage of PD-L1, EGFR/ALK, KRAS test performed along with results
Time frame
Restrospective data capture from January 2018 to January 2021.2
PD-L1 Biomarker profile evaluation at NSCLC diagnosis
Percentage of PD-L1 test performed along with results
Time frame
Restrospective data capture from January 2018 to January 2021.3
EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis
Percentage of EGFR/ALK test performed along with results
Time frame
Restrospective data capture from January 2018 to January 2021.4
KRAS Biomarkers profile evaluation at NSCLC diagnosis
Percentage of KRAS test performed along with result
Time frame
Restrospective data capture from January 2018 to January 2021.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MSD Italia S.r.l.
Lead sponsor
YGHEA, CRO Division of Ecol Studio spa
Collaborator
Source ClinicalTrials.gov