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

NCT06467383 | Recruiting

• 1 other identifier: NIS009903
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 25

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).

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

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  Restrospective data capture from January 2018 to January 2021.

Secondary Outcomes (1)

• NSCLC treatments timeline in Real-World practice

  Restrospective data capture from January 2018 to January 2021.

Other Outcomes (4)

• Biomarkers profile evaluation at NSCLC diagnosis

  Restrospective data capture from January 2018 to January 2021.

• PD-L1 Biomarker profile evaluation at NSCLC diagnosis

  Restrospective data capture from January 2018 to January 2021.

• EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis

  Restrospective data capture from January 2018 to January 2021.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MSD Italia S.r.l.: lead
• YGHEA, CRO Division of Ecol Studio spa: collaborator

Study Sites (25)

IRCCS Casa di sollievo dalla sofferenza

San Giovanni Rotondo, FG, Italy

NOT YET RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, Italy

NOT YET RECRUITING

Gemelli Molise

Campobasso, Italy

NOT YET RECRUITING

Humanitas Istituto Clinico Catanese

Catania, Italy

NOT YET RECRUITING

Policlinico Rodolico

Catania, Italy

NOT YET RECRUITING

AOU Careggi

Florence, Italy

RECRUITING

IRCCS Policlinico S. Martino

Genova, Italy

RECRUITING

AO Papardo

Messina, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Istituto Clinico Humanitas

Milan, Italy

RECRUITING

Istituto Nazionale dei Tumori - Fondazione IRCCS

Milan, Italy

NOT YET RECRUITING

AOU dei Colli - Monaldi

Napoli, Italy

NOT YET RECRUITING

AOU Vanvitelli

Napoli, Italy

RECRUITING

A.O.U. Maggiore della Carità di Novara

Novara, Italy

RECRUITING

IOV - Istituto Oncologico veneto - IRCCS

Padua, Italy

NOT YET RECRUITING

AOUP Policlinico Giaccone

Palermo, Italy

NOT YET RECRUITING

Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia

Perugia, Italy

NOT YET RECRUITING

Azienda USL Toscana Centro - Ospedale san Jacopo

Pistoia, Italy

RECRUITING

Centro di Riferimento Oncologico IRCCS

Pordenone, Italy

NOT YET RECRUITING

Azienda Ospedaliera Regionale San Carlo di Potenza

Potenza, Italy

NOT YET RECRUITING

AUSL Romagna Ospedale Santa Maria delle Croci Ravenna

Ravenna, Italy

NOT YET RECRUITING

IRCCS AUSL Reggio Emilia

Reggio Emilia, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario "A. Gemelli"

Roma, Italy

NOT YET RECRUITING

ASST dei Sette Laghi

Varese, Italy

NOT YET RECRUITING

AOUI Verona

Verona, Italy

NOT YET RECRUITING

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Related Links

• Globocan 2020

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Giada Iuliano, MD

  MSD Italia srl

  STUDY CHAIR

Central Study Contacts

Daniele Righi, PM

CONTACT

+39 051 5878211; d.righi@yghea.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: June 25, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (25)