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

NCT05732974 | Recruiting

• 1 other identifier: RC31/21/0519
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer Stage IIIA

Keywords

Machine-learning; Resected early stage Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Algorithm for disease free survival

  Analysis on a training cohort of resected early-stage non small cell lung cancer

  18 months

Study Arms (1)

Resected early stage non small cell lung cancer

Early stage (IA-IIIA) resectable non small cell lung cancer patients receiving surgery

Other: Resected non small cell lung cancer

Interventions

Resected non small cell lung cancer OTHER

plasma sample, tissue sample and computed tomography scan images

Resected early stage non small cell lung cancer

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

Patient with an early stage of non small cell lung cancer with an indication of surgical resection

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Julien MAZIERES

Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

biomarkers detected on plasma and tissue samples for analysis of circulating and extracellular vesicles-derived microRNAs as well as of free circulating DNA performed

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

• Julien MAZIERES, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien MAZIERES, MD, PhD

CONTACT

0567771837; mazieres.j@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: February 17, 2023
• Study Start: March 30, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)