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Lung CancerBREATHENCT06481813

Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients

A study testing Blood Sampling (2*8mL Tubes), PBMC Sampling (1*8mL Tubes) and Paxgene Sampling in people with Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Nantes University Hospital at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Blood Sampling (2*8mL Tubes), PBMC Sampling (1*8mL Tubes) and Paxgene Sampling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
730 participants
Where
4 sitesFrance
Study dates
10 Dec 2024to 1 Dec 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients :
  • Adult
  • Patient newly diagnosed with NSCLC or CPC
  • Cared for at Nantes University Hospital
  • Affiliated or beneficiaries of a social security scheme or similar
  • Treated with a systemic therapy including chemotherapy and/or immunotherapy and/or targeted therapy and/or therapy as part of a clinical trial after agreement from the sponsors of the studies concerned (only in the absence of blinding).
Show all 26Show fewer
  • Having agreed to participate in this study by signing the biocollection consent.
  • Healthy subjects :
  • Adult
  • Affiliated or beneficiaries of a social security or similar scheme
  • Who have agreed to participate in this study by signing the Biocollection consent form.
  • No known infectious pathology
  • No known history of cancer
  • No known history of chronic autoimmune disease
  • No background immuno-suppressive treatment
  • Ancillary Study :
  • -Metastatic NSCLC with a KRAS G12C mutation, receiving treatment with Sotorasib, Adagrasib, or another KRAS G12C inhibitor, either as monotherapy or in combination.
  • Patients under guardianship
  • Patients with AME.
  • Pregnant or breast-feeding women
  • Healthy subjects :
  • Person under guardianship
  • Person benefiting from AME (State medical aid)
  • Pregnant or breast-feeding women
  • Ancillary Study :
  • Pregnant or breast-feeding women

Who cannot join

  • Patients :
  • Previous anticancer treatment for Lung cancer
  • Patients who have not consented to participate in the BREATHE collection
  • History of cancer (excluding thoracic cancer) with evidence of disease for less than 2 years

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elvire PONS-TOSTIVINT, MD PhD contact

02.40.16.59.30

elvire.pons@chu-nantes.fr

France4 sites, 4 recruiting
  • CHU d'Angers

    Angers

    Grégoire JUSTEAU, MD, PhD, +33 2 41 35 36 37, gregoire.justeau@chu-angers.fr

    Grégoire JUSTEAU

    Not yet recruiting
  • CHU Nantes

    Nantes

    Elvire PONS-TOSTIVINT, MD, PhD, 02 40 16 59 30, elvire.pons@chu-nantes.fr

    Recruiting
  • CHU Rennes

    Rennes

    Charles RICORDEL, MD, PhD, +33 2 99 28 37 38, Charles.RICORDEL@chu-rennes.fr

    Charles RICORDEL

    Not yet recruiting
  • CHU Tours

    Tours

    Marion FERREIRA, MD, PhD, +33 2.47.47.37.87, marion.ferreira@chu-tours.fr

    Marion FERREIRA

    Not yet recruiting

Other trials in France

About this study

Official title: BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients

In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study).

In parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.

Being tested
Blood Sampling (2*8mL Tubes), PBMC Sampling (1*8mL Tubes), Paxgene Sampling, Extended biopsies of tumor lesions
Keywords
Real-world cohort, Lung Cancer, Biobank
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Sampling (2*8mL Tubes)Other

    Patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)

  • PBMC Sampling (1*8mL Tubes)Other

    Patients will be sampled from 1 x 8 mL PBMC

  • Paxgene SamplingOther

    Patients will be sampled from 1 x 8 mL of blood with Paxgene Tube

  • Extended biopsies of tumor lesionsProcedure or surgery

    Regarding the ancillary study, as part of the care, patients are biopsied at diagnosis and during relapse(s). For metastatic patients with multiple sites, one site (the most accessible) is chosen and biopsied in interventional radiology or pulmonology.

    The material used is: 17-18G biopsy needle / Sampling chamber volume of 0.01 cm³ to 0.02 cm³.

    For a standard biopsy as part of the care, 3 samples are taken (total volume of 0.03 cm³ to 0.06 cm³). Inclusion in the ancillary study would add one sample using the same biopsy path, resulting in an additional volume of 0.01 cm³ to 0.02 cm³.

    In the case of a complex biopsy, no additional sampling related to the research will be performed.

Study groups in NCT06481813
Study groupRoleWhat they receive
Cohort AOtherPatients are prospectively enrolled the day before their surgery for lung cancer, following selection based on tumor size assessed by the latest CT scan. The lesion size must be ≥ 20 mm (to prioritize anatomopathological analyses performed as part of care). If patients receive adjuvant treatment, blood samples will be collected on the day of treatment initiation and during follow-up. Patients receiving neoadjuvant treatment will be enrolled at the time of their first consultation with the medical oncologist. Patients in this cohort must meet the following criteria: - Stage I / II / IIIA-B localized NSCLC (non-small-cell lung cancer) eligible for surgery and adjuvant or neoadjuvant therapy (15-20% of NSCLC) Intervention : patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
Receives: Other: Blood Sampling (2*8mL Tubes)
Cohort BOtherPatients are prospectively enrolled at the diagnosis of lung neoplasm, during the establishment of the therapeutic plan by the referring oncologist or pneumo-oncologist. Enrollment can also occur at the initiation of first-line treatment if it was not done at the time of the diagnostic consultation. Patients in this cohort must meet the following criteria: - metastatic NSCLC or SCLC (small-cell bronchial cancers), with drained or punctured pleural effusion and anatomopathological evidence of tumor cells Intervention, the following volumes of blood will be drawn at each visit : * 2*8ml (EDTA tubes) * 1*8mL PBMC (only for patients receiving immunotherapy, collected before the 1st course of treatment, before the 2nd course of treatment, and at relapse) * 1*6mL Paxgene (only for patients with lung cancer of non-epidermoid histology, collected at 1st treatment, 2nd treatment and relapse)
Receives: Other: Blood Sampling (2*8mL Tubes); Other: PBMC Sampling (1*8mL Tubes); Other: Paxgene Sampling
Cohort COtherCohort C patients are recruited in the same way as for cohort B. Patients in this cohort must meet the following criteria: * Metastatic NSCLC receiving systemic chemotherapy, immunotherapy and/or targeted therapy * Locally advanced stage III NSCLC treated with radio-chemotherapy +/- immunotherapy * Extra-thoracic SCLC treated with chemotherapy +/- immunotherapy * Intra-thoracic SCLC treated with radio-chemotherapy Intervention, the following volumes of blood will be drawn at each visit : * 2*8ml (EDTA tubes) * 1*8mL PBMC (only for patients receiving immunotherapy, collected before the 1st course of treatment, before the 2nd course of treatment, and at relapse) * 1*6mL Paxgene (only for patients with lung cancer of non-epidermoid histology, collected at 1st treatment, 2nd treatment and relapse)
Receives: Other: Blood Sampling (2*8mL Tubes); Other: PBMC Sampling (1*8mL Tubes); Other: Paxgene Sampling
Cohort BMBOtherPatients are enrolled preoperatively, at the diagnosis of metastatic lung cancer at the cerebral level. The patient signs consent preoperatively (consent provided by the neurosurgeon). Subsequently, they are prospectively followed as part of their management in medical oncology, postoperatively. Patients in this cohort must meet the following criteria: - Patient operated on for brain metastasis as part of care, and diagnosed with lung cancer. Intervention, the following volumes of blood will be drawn at each visit : * 2*8ml (EDTA tubes) * 1*8mL PBMC (only for patients receiving immunotherapy, collected before the 1st course of treatment, before the 2nd course of treatment, and at relapse) * 1*6mL Paxgene (only for patients with lung cancer of non-epidermoid histology, collected at 1st treatment, 2nd treatment and relapse)
Receives: Other: Blood Sampling (2*8mL Tubes); Other: PBMC Sampling (1*8mL Tubes); Other: Paxgene Sampling
Healthy Controls :OtherA population of healthy subjects will also be included. These healthy subjects will be either : * Companions of patients with lung cancer who have come to the oncology clinic for their loved ones. * Patients who have undergone atypical lung resection as part of their care for pneumothorax. Intervention : Healthy subject will be sampled from 2 x 8 mL blood tubes (EDTA tubes) In addition to blood samples from healthy subjects, healthy tissue remnants from atypical lung resections performed as part of care for pneumothorax management will be used to analyze the study objectives. A maximum of 30 healthy subjects are expected in this population.
Receives: Other: Blood Sampling (2*8mL Tubes)
Ancillary studyOtherPatients included in the other arms of the cohort may also participate in the ancillary study if they meet the following conditions : Being carriers of metastatic KRAS G12C mutated NSCLC with a treatment plan involving sotorasib, adagrasib, or another KRAS inhibitor, either alone or in combination with another treatment. A target of 40 patients (among the 700 patients included in the cohort, excluding healthy subjects) is set for the ancillary study.
Receives: Procedure: Extended biopsies of tumor lesions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival will be defined as the time elapsed between the date of the initial diagnosis of lung cancer and the date of death, regardless of the cause. Patients still alive at the end of the follow-up period will complete their participation in the cohort.

    Measured: up to 5 years

Secondary outcomes (4)
  1. Describe the care pathway for patients with lung cancer. Assess the time intervals between different steps in the initial management of lung cancer.

    The care pathway will be described through the collection of dates (surgery, radiotherapy, presentation at multidisciplinary consultation meetings, etc.) and types of medical consultations.

    Measured: up to 5 years

  2. Evaluate the return to work for patients of working age who have been treated for lung cancer.

    Proportion of patients who returned to work after treatment, measurement of the average time taken, and factors associated with the return to work.

    Measured: up to 5 years

  3. Identify specific biomarkers of lung cancer cells (primary tumors or metastatic tissues) in comparison to healthy lung tissues.

    Quantitative comparison and characterization of biomarkers (extracellular vesicles and miRNA signatures) between tumor tissues and non-cancerous tissues.

    Measured: up to 5 years

  4. Evaluate the prognostic and predictive value of circulating biomarkers at diagnosis and during systemic treatments.

    Association between levels of circulating biomarkers and overall survival as well as treatment response.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start10 Dec 2024
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 2034 (estimated)

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This cohort will include 5 distinct patient populations.
Masking
None (open label)
Enrolment
730 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481813
Sponsor's protocol ID
RC21_0541
Other IDs
2024-A00509-38
Acronym
BREATHE
Status last verified
Sep 2026
First submitted
23 May 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Blood Sampling (2*8mL Tubes), PBMC Sampling (1*8mL Tubes) and Paxgene Sampling in people with Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Nantes University Hospital at 4 sites 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 26 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elvire PONS-TOSTIVINT, MD PhD (02.40.16.59.30, elvire.pons@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: up to 5 years). 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 5 Oct 2026.

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