NsclcLUNGDOCNCT05165160
Residual Disease Evaluation of Resected NSCLC by cirDNA Analysis
A study testing Blood sample in people with Nsclc, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nsclc
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2022to 2 Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Undertaking of Resected Non-small Cell Lung Cancer by Generating a Residual Disease Outline Based on Circulating Cell-free DNA
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.
Read the 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.
- Conditions
- Nsclc
- Being tested
- Blood sample
- Keywords
- Stage I to IIIA, Performance status 0-2, Written and signed informed consent form
- 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.
Blood sampleDiagnostic test
Pre- and postoperative blood sample
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | Experimental | Not described Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival probability according to MiTest at one year after surgery (RFS1)
Measured: The year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start15 Feb 2022
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NsclcStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165160
- Sponsor's protocol ID
- RECHMPL20_0548
- Acronym
- LUNGDOC
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Undertaking of Resected Non-small Cell Lung Cancer by Generating a Residual Disease Outline Based on Circulating Cell-free DNA
- ClinicalTrials.gov ID
- NCT05165160
- Acronym / sponsor ID
- LUNGDOC / RECHMPL20_0548
- Conditions
- Nsclc
- Keywords
- Stage I to IIIA, Performance status 0-2, Written and signed informed consent form
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 21 Dec 2021 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | Experimental | Diagnostic Test: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Blood samplePre- and postoperative blood sample | Diagnostic test | Eligible patients |
Primary outcome
Recurrence-free survival probability according to MiTest at one year after surgery (RFS1)
Time frame: The year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Nsclc, run by University Hospital, Montpellier 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 22 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival probability according to MiTest at one year after surgery (RFS1) (time frame: The year after surgery). 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 22 Jun 2026.