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NCT Number: NCT06481813

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Lung Cancer Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).
  • 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.

Exclusion criteria

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
  • Inclusion in a therapeutic trial with blinded treatment
  • 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

Treatment and study plan

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 Sampling

Other

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

Extended biopsies of tumor lesions

Procedure

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.

Primary outcomes

  1. Overall survival

    Time frame: up to 5 years

    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.

Secondary outcomes

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

    Time frame: up to 5 years

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

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

    Time frame: up to 5 years

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

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

    Time frame: up to 5 years

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

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

    Time frame: up to 5 years

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

Other outcomes

  1. Predicting the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.

    Time frame: up to 5 years

  2. Determining the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.

    Time frame: up to 5 years

  3. Determining whether transcriptional changes under sotorasib or adagrasib can predict progression-free survival in patients with metastatic KRAS G12C-mutated NSCLC.

    Time frame: up to 5 years

  4. Assessing the prognostic value of detecting specific molecular alterations occurring under treatment.

    Time frame: up to 5 years

  5. Identifying whether new molecular alterations can be detected in tumor and plasma samples from patients at progression.

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Elvire PONS-TOSTIVINT, MD PhD

CONTACT

[email protected]

02.40.16.59.30

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: BREATHE

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Jul 1, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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