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Trial Title:
Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
NCT ID:
NCT06481813
Condition:
Lung Cancer
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Metastatic Lung Cancer
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Conditions: Keywords:
Real-world cohort
Lung Cancer
Biobank
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This cohort will include 5 distinct patient populations.
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood Sampling (2*8mL Tubes)
Description:
Patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort BMB
Arm group label:
Cohort C
Arm group label:
Healthy Controls :
Intervention type:
Other
Intervention name:
PBMC Sampling (1*8mL Tubes)
Description:
Patients will be sampled from 1 x 8 mL PBMC
Arm group label:
Cohort B
Arm group label:
Cohort BMB
Arm group label:
Cohort C
Intervention type:
Other
Intervention name:
Paxgene Sampling
Description:
Patients will be sampled from 1 x 8 mL of blood with Paxgene Tube
Arm group label:
Cohort B
Arm group label:
Cohort BMB
Arm group label:
Cohort C
Intervention type:
Procedure
Intervention name:
Extended biopsies of tumor lesions
Description:
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.
Arm group label:
Ancillary study
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. 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
December 1, 2024
Completion date:
December 1, 2034
Lead sponsor:
Agency:
Nantes University Hospital
Agency class:
Other
Source:
Nantes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06481813
