Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult
Patient newly diagnosed with NSCLC or CPC
Cared for at Nantes University Hospital
Affiliated or beneficiaries of a social security scheme or similar
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Blood Sampling (2*8mL Tubes)
Other interventionPatients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
PBMC Sampling (1*8mL Tubes)
Other interventionPatients will be sampled from 1 x 8 mL PBMC
Paxgene Sampling
Other interventionPatients will be sampled from 1 x 8 mL of blood with Paxgene Tube
Extended biopsies of tumor lesions
Procedure/SurgeryRegarding 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.
Treatment groups
730 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort AOther 1 intervention
Group B: Cohort BOther 3 interventions
Group C: Cohort COther 3 interventions
Group D: Cohort BMBOther 3 interventions
Group E: Healthy Controls :Other 1 intervention
Group F: Ancillary studyOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
up to 5 yearsSecondary 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.
The care pathway will be described through the collection of dates (surgery, radiotherapy, presentation at multidisciplinary consultation meetings, etc.) and types of medical consultations.
Time frame
up to 5 years2
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.
Time frame
up to 5 years3
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.
Time frame
up to 5 years4
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.
Time frame
up to 5 yearsOther 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 years2
Determining the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.
Time frame
up to 5 years3
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 years4
Assessing the prognostic value of detecting specific molecular alterations occurring under treatment.
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov