Development of Clinical and Biological Database on Bronchial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and tissue sampling.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Bronchial Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Prospective Monocentric Clinico-Biological Database for Bronchial Cancer
Overview
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to bronchial cancer.
Detailed description
Lung cancer is the leading cause of cancer-related mortality and the third most commonly diagnosed cancer. In France in 2018, it accounted for 46,363 new cases and 33,117 deaths. The overall 5-year survival rate across all stages and sexes is 20%.
Diagnosis is most often made at the metastatic stage, which significantly worsens the prognosis. Since 2020, the standard treatment for such cases has been the administration of intravenous chemo-immunotherapy, in the absence of a molecular alteration that allows for access to an oral targeted therapy. Immunotherapy and targeted therapies have considerably improved the prognosis for some patients, but the vast majority experience therapeutic resistance, either early or delayed.
The prognostic and predictive mechanisms of treatment response are poorly understood and vary greatly between histological and molecular subtypes. It is therefore crucial to gain a better understanding of these mechanisms in order to ultimately identify new therapeutic avenues to improve patient outcomes.
The first step in this process is to establish a tissue and blood biobank from patients with bronchial carcinoma (both small-cell and non-small-cell) treated at our center.
The Clinical Biological DataBase (BCB) is a tool:
* for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials; * to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations; * to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
Interventions
- Biological Blood and tissue sampling
Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. During the blood samples taken for diagnosis and / or treatment when possible. Additional samples for research purposes will be carried out, these blood samples will be collected: * before any therapeutic intervention (T1) for a total volume of 36mL, * prior to surgery (T-Surg) for a total volume of 24mL, * at each progression (T2a, b, c…) for a total volume of 24mL, * at the end of follow
Primary outcome measures
- Proportion of patients who consent to participate in the study [Time frame: through study completion : an average of 1 year]
Eligibility criteria
Inclusion criteria
- Male or female patient aged over 18 years,
- Histologically or cytologically confirmed bronchial cancer,
- Treatment-naïve patient for the current cancer,
- Patient who has provided informed, written, and explicit consent,
- Patient affiliated with the French national health insurance system.
Exclusion criteria
- Patient with a WHO performance status ≥ 3,
- Pregnant and/or breastfeeding woman,
- Patient with a history of other cancers within the 5 years preceding inclusion,
- Patient for whom regular follow-up is considered impossible due to psychological, familial, social, or geographic reasons,
- Patient under legal protection (guardianship, curatorship, or judicial protection).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle — Montpellier
Identifiers
NCT: NCT07085429 · PROICM 2021-11 BPO