Residual Disease Evaluation of Resected NSCLC by cirDNA Analysis (NCT05165160) | Clinical Trial Compass
CompletedNot Applicable
Residual Disease Evaluation of Resected NSCLC by cirDNA Analysis
France133 participantsStarted 2022-02-15
Plain-language summary
Prognosis of resectable early stages NSCLC might be improved by a better knowledge of post-operative minimal residual disease (MRD). This could be achieved by studying patient with stage I to IIIA completely resected-NSCLC, comparing qualitative and quantitative features of pre- and post-operative circulating cell-free DNA (cirDNA), using MiTest. We assume that the evolution of the parameters of MiTest and relapse rate after surgery are related and expect to prove that normalization of MiTest at one month after surgery is a prognostic factor of reduced relapse at one year.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 years or older
* Patients with a resectable NSCLC
* Definite stage I to IIIA
* Performance status of 0, 1 or 2
* Normal end organ functions
* Written and signed informed consent form
* Subjects must be covered by public health insurance.
Exclusion Criteria:
* Any previous systemic neoadjuvant treatment: targeted therapy, chemotherapy, immune checkpoint blockade
* Previous radiotherapeutic neoadjuvant treatment
* Resection margins R1 and R2
* Non-invasive lung carcinoma
* Multiple primary lung cancer.
* Previous malignancy during the past 3 years (except non-melanomatous skin cancer)
* Preexisting interstitial lung disease
* known HIV, active viral B hepatitis or C hepatitis
* Patient with any other situation responsible for cirDNA rate increasing (active auto-immune disease, 10 days following blood transfusion)
* Patient unable to attend all scheduled visits
* Woman of childbearing age without efficient contraception, breastfeeding
* Patient with a legal protection measure (guardianship, curatorship)
* Vulnerable patient protected by law
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence-free survival probability according to MiTest at one year after surgery (RFS1)