A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced

MSD Italia S.r.l.600 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Non-small Cell Lung Cancer NSCLC NSCLC, Stage III NSCLC, Stage I

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

IRCCS Casa di sollievo dalla sofferenza

San Giovanni Rotondo, FG, Italy

Outcomes

Primary Outcomes

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.

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 2021

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.

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

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.

Central Contacts

Daniele Righi, PM

CONTACT

+39 051 5878211 d.righi@yghea.it

Data from ClinicalTrials.gov

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