Non-small Cell Lung Cancer Stage IIIAMIRACLENCT05732974
A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse
An observational study of Non-small Cell Lung Cancer Stage IIIA, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIA
- What is being tested?
- Resected non small cell lung cancer
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2023to 30 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an early stage of non small cell lung cancer with an indication of surgical resection
Who may be able to join
- 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
Who cannot join
- Patient with another cancer in the last 5 years
- Patient with an allergy to the contrast medium
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Julien MAZIERES
Toulouse, 31059
Julien MAZIERES, 0567771837, mazieres.j@chu-toulouse.fr
Julie MILIA, milia.j@chu-toulouse.fr
About this study
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Being tested
- Resected non small cell lung cancer
- Keywords
- Machine-learning, Resected early stage Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resected non small cell lung cancerOther
plasma sample, tissue sample and computed tomography scan images
| Study group | Role | What they receive |
|---|---|---|
| Resected early stage non small cell lung cancer | Early stage (IA-IIIA) resectable non small cell lung cancer patients receiving surgery Receives: Other: Resected non small cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm for disease free survival
Analysis on a training cohort of resected early-stage non small cell lung cancer
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start30 Mar 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIAStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien MAZIERES, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732974
- Sponsor's protocol ID
- RC31/21/0519
- Acronym
- MIRACLE
- Status last verified
- Sep 2023
- First submitted
- 14 Nov 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Approach to Identify Patients With Resected Non-small-cell Lung Cancer With High Risk of Relapse
- ClinicalTrials.gov ID
- NCT05732974
- Acronym / sponsor ID
- MIRACLE / RC31/21/0519
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Keywords
- Machine-learning, Resected early stage Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resected early stage non small cell lung cancer | – | Other: Resected non small cell lung cancerEarly stage (IA-IIIA) resectable non small cell lung cancer patients receiving surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an early stage of non small cell lung cancer with an indication of surgical resection
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient with another cancer in the last 5 years
- Patient with an allergy to the contrast medium
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resected non small cell lung cancerplasma sample, tissue sample and computed tomography scan images | Other | Resected early stage non small cell lung cancer |
Primary outcome
Algorithm for disease free survival
Time frame: 18 months
Analysis on a training cohort of resected early-stage non small cell lung cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien MAZIERES, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Stage IIIA, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien MAZIERES, MD, PhD (0567771837 ext. 33, mazieres.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm for disease free survival (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.