Clinical trial NCT06467383: A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
Official title: A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
NSCLC
NSCLC, Stage III
NSCLC, Stage I
Keywords: NSCLC early stage
NSCLC locally advanced
retrospective observational study
Real-World Evidence
Lead sponsor: MSD Italia S.r.l.
Sponsor class: INDUSTRY
Collaborators: name: YGHEA, CRO Division of Ecol Studio spa
First posted: 2024-06-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NSCLC treatment approaches in Real-World practice
timeFrame: Restrospective data capture from January 2018 to January 2021.
measure: Percentage of patients discusses in multidisciplinary team
timeFrame: Restrospective data capture from January 2018 to January 2021
measure: Healthcare resource utilization aof different therapeutic approaches
timeFrame: Restrospective data capture from January 2018 to January 2021.
measure: Direct medical costs of different therapeutic approaches
timeFrame: Restrospective data capture from January 2018 to January 2021.
Secondary outcomes:
measure: NSCLC treatments timeline in Real-World practice
timeFrame: Restrospective data capture from January 2018 to January 2021.
Other outcomes:
measure: Biomarkers profile evaluation at NSCLC diagnosis
timeFrame: Restrospective data capture from January 2018 to January 2021.
measure: PD-L1 Biomarker profile evaluation at NSCLC diagnosis
timeFrame: Restrospective data capture from January 2018 to January 2021.
measure: EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis
timeFrame: Restrospective data capture from January 2018 to January 2021.
measure: KRAS Biomarkers profile evaluation at NSCLC diagnosis
timeFrame: Restrospective data capture from January 2018 to January 2021.
Locations:
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa di sollievo dalla sofferenza
state: FG
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Campobasso
country: Italy
facility: Gemelli Molise
city: Catania
country: Italy
facility: Humanitas Istituto Clinico Catanese
city: Catania
country: Italy
facility: Policlinico Rodolico
city: Firenze
country: Italy
facility: AOU Careggi
city: Genova
country: Italy
facility: IRCCS Policlinico S. Martino
city: Messina
country: Italy
facility: AO Papardo
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Istituto Clinico Humanitas
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori - Fondazione IRCCS
city: Napoli
country: Italy
facility: AOU dei Colli - Monaldi
city: Napoli
country: Italy
facility: AOU Vanvitelli
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità di Novara
city: Padova
country: Italy
facility: IOV - Istituto Oncologico veneto - IRCCS
city: Palermo
country: Italy
facility: AOUP Policlinico Giaccone
city: Perugia
country: Italy
facility: Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia
city: Pistoia
country: Italy
facility: Azienda USL Toscana Centro - Ospedale san Jacopo
city: Pordenone
country: Italy
facility: Centro di Riferimento Oncologico IRCCS
city: Potenza
country: Italy
facility: Azienda Ospedaliera Regionale San Carlo di Potenza
city: Ravenna
country: Italy
facility: AUSL Romagna Ospedale Santa Maria delle Croci Ravenna
city: Reggio Emilia
country: Italy
facility: IRCCS AUSL Reggio Emilia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario "A. Gemelli"
city: Varese
country: Italy
facility: ASST dei Sette Laghi
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
affiliation: MSD Italia srl
name: Giada Iuliano, MD
role: STUDY_CHAIR
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