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

September 18, 2023 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm for disease free survival
Time Frame: 18 months
Analysis on a training cohort of resected early-stage non small cell lung cancer
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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