Development of Clinical and Biological Database on Bronchial Cancer

NCT ID: NCT07085429

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2040-09-30

Brief Summary

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.

Conditions

Lung Cancer; Bronchial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Bronchial cancer

Additionnal samples from routine care of different natures (blood, tumor tissue ans healthy tissue) and standardized clinical data will be entered into a database.

Group Type: EXPERIMENTAL

Blood and tissue sampling

Intervention Type: BIOLOGICAL

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-up (T3) for a total volume of 24mL.

Interventions

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-up (T3) for a total volume of 24mL.

Intervention Type: BIOLOGICAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, France, France

Countries

France

Central Contacts

Emmanuelle TEXIER

Role: CONTACT

emmanuelle.texier@icm.unicancer.fr

467613102 ext. +33

Facility Contacts

Marc Ychou, MD, PhD

Role: primary

marc.ychou@icm.unicancer.fr

467613066 ext. +33

Aurore MOUSSION

Role: backup

aurore.moussion@icm.unicancer.fr

467613102 ext. +33

Other Identifiers

PROICM 2021-11 BPO

Identifier Type: -

Identifier Source: org_study_id