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

Non-small Cell Lung Cancer Clinical Trial

— Key-Early  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467383
• Other study ID #: NIS009903
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: June 19, 2025

Study information

• Verified date: June 2024
• Source: MSD Italia S.r.l.
• Contact: Daniele Righi Project Manager
• Phone: +39 051 5878211
• Email: d.righi[@]yghea.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 19, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 & privacy Form (ICF), if applicable (see section 5.1.1 for details on consent collection for Deceased patients and Untraceable patients).

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer
• NSCLC
• NSCLC, Stage I
• NSCLC, Stage III

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MSD Italia S.r.l.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients undergoing surgery for early stage or locally advanced NSCLC	Curative surgery, defined as surgical resection of the lung cancer (i.e. lobectomy, pneumonectomy, segmental resection, or other) with curative intent	Restrospective data capture from January 2018 to January 2021.
Primary	Percentage of patients discusses in multidisciplinary team		Restrospective data capture from January 2018 to January 2021
Primary	Percentage of patient receiving neoadjuvant and/or adjuvant treatment and percentage of patient undergoing definitive (chemo)radiotherapy	Concurrent (or concomitant) chemoradiotherapy, defined as any regimen of chemotherapy administered with concurrent radiotherapy. Sequential chemoradiotherapy, defined either as any regimen of chemotherapy followed by at least one session of radiotherapy, or at least one radiotherapy course followed by at least one cycle of chemotherapy; in order to be defined as sequential chemoradiotherapy, tumor resection shall not be performed between chemotherapy and radiotherapy or vice versa.	Restrospective data capture from January 2018 to January 2021.
Primary	Healthcare resource utilization and direct medical costs on different therapeutic approach	Cost of illness, defined as the total key-resources cost for each patient (i.e. visits and other physician services including surgery and radiotherapy cost, hospitalization, diagnostic procedures and tests, routine laboratory, disease assessment, administered drugs)	Restrospective data capture from January 2018 to January 2021.