- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165160
Residual Disease Evaluation of Resected NSCLC by cirDNA Analysis (LUNGDOC)
Local Undertaking of Resected Non-small Cell Lung Cancer by Generating a Residual Disease Outline Based on Circulating Cell-free DNA
Study Overview
Detailed Description
Rationale: Non-small cell lung cancer (NSCLC) is the most lethal cancer worldwide with an increasing incidence each year and a better prognosis for resectable early stages, despite frequent recurrences. Yet, oncologic adjuvant cares are decided without accurate information about minimal residual disease (MRD).
The improvement of post-operative management of early-stage NSCLC supposes to better understand post-operative MRD. In a cancer screening study performed recently, we showed that nuclear and mitochondrial circulating cell-free DNA (cirDNA) are significantly modified in cancer situation and might stand as promising surrogates of MRD. The analysis of cirDNA in blood with quantitative PCR (qPCR), through the use of multi-analyte test called MiTest, could offer a very sensitive study model of MRD in patients with resected NSCLC. We assume that the evolution of these parameters 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.
Main objective: Our main objective is to determine whether the lack of normalization of MiTest of cirDNA one month after the resection of an early-stage NSCLC is predictive of relapse rate at 1 year.
Methodology: The RD-CD LUNGDOC Project is a monocentric, prospective, interventional, non-comparative, single-arm prognostic exploratory study in which we estimated 120 patients as the number of subjects needed. Subjects will be included consecutively at the Montpellier Academic Hospital and blood sampled at 3 timepoints: once before surgery and twice after surgery, at one month and one year.
Main inclusion criteria: patients with resected NSCLC, stage I to IIIA, performance status 0-2, normal end organ functions.
Main non-inclusion criteria: previous systemic neoadjuvant treatment, resection margins R1 and R2, neoadjuvant treatment received, non-invasive lung carcinoma, multiple primary lung cancer, previous malignancy during the past 3 years, concomitant primitive malignant disease.
Primary endpoint: Recurrence- free survival (RFS) probability according to MiTest at 1 year after surgery.
Secondary endpoints: Overall survival (OS) probability according to MiTest at one month and at one-year post-surgery, qualitative and quantitative features of cirDNA.
Feasibility: CirDNA analysis will be performed at the Montpellier Cancer Research Institute in the of Alain THIERRY's team "Biomarkers in precision oncology team".
Expected results and prospects: We expect to prove that normalization of MiTest at one month after surgery is a prognostic factor for patients with resected NSCLC, which could deeply modify management of resected NSCLC by better stratifying prognosis and possibly anticipating relapses.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benoit ROCH, MD
- Phone Number: +333467330739
- Email: b-roch@chu-montpellier.fr
Study Locations
-
-
-
Montpellier, France, 34295
- Recruiting
- university Hospital
-
Contact:
- Benoit ROCH, MD
- Phone Number: +333467330739
- Email: b-roch@chu-montpellier.fr
-
Principal Investigator:
- Benoit ROCH, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eligible patients
|
Pre- and postoperative blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence-free survival probability according to MiTest at one year after surgery (RFS1)
Time Frame: The year after surgery
|
The year after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL20_0548
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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