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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05732974
Collaborator
(none)
60
1
44
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Resected non small cell lung cancer

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Oct 30, 2026

Arms and Interventions

Arm Intervention/Treatment
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
plasma sample, tissue sample and computed tomography scan images

Outcome Measures

Primary Outcome Measures

  1. Algorithm for disease free survival [18 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Julien MAZIERES Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Julien MAZIERES, MD, PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05732974
Other Study ID Numbers:
  • RC31/21/0519
First Posted:
Feb 17, 2023
Last Update Posted:
Feb 17, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2023