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

NCT06481813 | Recruiting

• 2 other identifiers: RC21_05412024-A00509-38
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Metastatic Lung Cancer

Keywords

Real-world cohort; Lung Cancer; Biobank

Outcome Measures

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.

  up to 5 years

Secondary Outcomes (4)

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

  up to 5 years

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

  up to 5 years

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

  up to 5 years

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

  up to 5 years

Other Outcomes (5)

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

  up to 5 years

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

  up to 5 years

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

  up to 5 years

Study Arms (6)

Cohort A

OTHER

Patients 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)

Other: Blood Sampling (2*8mL Tubes)

Cohort B

OTHER

Patients 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)

Other: Blood Sampling (2*8mL Tubes); Other: PBMC Sampling (1*8mL Tubes); Other: Paxgene Sampling

Cohort C

OTHER

Cohort 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)

Other: Blood Sampling (2*8mL Tubes); Other: PBMC Sampling (1*8mL Tubes); Other: Paxgene Sampling

Cohort BMB

OTHER

Patients 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)

Other: Blood Sampling (2*8mL Tubes); Other: PBMC Sampling (1*8mL Tubes); Other: Paxgene Sampling

Healthy Controls :

OTHER

A 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.

Other: Blood Sampling (2*8mL Tubes)

Ancillary study

OTHER

Patients 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.

Procedure: Extended biopsies of tumor lesions

Interventions

PBMC Sampling (1*8mL Tubes) OTHER

Patients will be sampled from 1 x 8 mL PBMC

Cohort B; Cohort BMB; Cohort C

Paxgene Sampling OTHER

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

Cohort B; Cohort BMB; Cohort C

Blood Sampling (2*8mL Tubes) OTHER

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

Cohort A; Cohort B; Cohort BMB; Cohort C; Healthy Controls :

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.

Ancillary study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Elvire PONS-TOSTIVINT, MD PhD

CONTACT

02.40.16.59.30; elvire.pons@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This cohort will include 5 distinct patient populations.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: July 1, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2034
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (1)