A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse

Non-small Cell Lung Cancer Stage IIIA Clinical Trial

— MIRACLE  

Official title:

A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732974
• Other study ID #: RC31/21/0519
• Status: Recruiting
• Start date: March 30, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: September 2023
• Source: University Hospital, Toulouse
• Contact: Julien MAZIERES, MD, PhD
• Phone: 0567771837
• Email: mazieres.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Early-stage non small cell lung cancer represents 20-30% of all non small cell lung cancer and is characterized by a high survival probability after surgical resection. However, considering stage IA-IIIA non small cell lung cancer, a relapse rate of about 50% is observed, with a different survival probability on the basis of tumor node metastasis status, although patients within the same tumor node metastasis stage exhibit wide variations in recurrence rate. There are currently no validated prognostic biomarkers able to identify patients with a high risk of relapse.

Description:

This study will use data from an already available cohort of patients enrolled in the Resting study (a project funded by TRANSCAN in 2018) as a training set and data from a new concurrent cohort as validation set.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with an early stage of non small cell lung cancer
• Indication of surgical resection
• Patient able to understand and give his consent
• Patient affiliated to the health insurance

Exclusion Criteria:

• Patient with another cancer in the last 5 years
• Patient with an allergy to the contrast medium
• Patient under legal protection

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage IIIA

Intervention

Other:
• Resected non small cell lung cancer
plasma sample, tissue sample and computed tomography scan images

Locations

Country	Name	City	State
France	Julien MAZIERES	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algorithm for disease free survival	Analysis on a training cohort of resected early-stage non small cell lung cancer	18 months