IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy (IMMUNOLUNG)
IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The primary objective of this clinical study is to understand how certain blood markers can predict the effectiveness of immunotherapy treatments for patients with advanced-stage lung cancer.
This is a multicenter study with a total duration of 7 years.
In addition, the study will address several secondary objectives:
Compare biological markers present in the blood with those found in lung cancer tumors.
Investigate differences between tumor markers at early versus advanced stages of the disease.
Identify new markers that may predict the effectiveness of immunotherapy treatments.
Explore a specific mechanism (called HVEM/BTLA) involved in lung cancer, whether at an early or advanced stage.
To achieve the study objectives, 200 patients are expected to be enrolled, and the study will be conducted across two institutions.
In this study, the following biological samples will be collected: blood and tissue samples at the time of inclusion, and again at disease progression if it occurs during follow-up.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jihane pakradouni
- Número de telefone: 0491223824
- E-mail: pakradounij@ipc.unicancer.fr
Estude backup de contato
- Nome: allison arthur
- Número de telefone: 0491223448
- E-mail: arthura@ipc.unicancer.fr
Locais de estudo
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Institut Paoli Calmettes
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Marseille, Institut Paoli Calmettes, França, 13009
- Recrutamento
- Rochigneux
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Contato:
- allison ARTHUR
- Número de telefone: 0491223448
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients aged 18 years or older, male or female.
- Willing to participate in the study and having signed a written informed consent form.
- Presenting a strong suspicion of localized resectable or advanced unresectable non-small cell lung cancer, or having a histologically confirmed non-small cell lung cancer.
- Affiliated with a social security system or benefiting from such a system.
Exclusion Criteria:
- Individuals in an emergency situation, adults under legal protection (guardianship, curatorship, or judicial protection), or individuals unable to provide informed consent.
- Inability to comply with the medical follow-up required by the study for geographical, social, or psychological reasons.
- History of solid organ transplantation or hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: patients with localized NSCLC
This project is based on the prospective collection of blood and tumor samples from NSCLC patients, along with the corresponding clinical data.One hundred patients with localized NSCLC will be enrolled at each participating center; these are patients with resectable NSCLC treated by surgery.
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The procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples. The protocol-mandated tumor sampling at progression will be performed in the following two situations:
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Outro: patients with advanced NSCLC
One hundred patients with advanced NSCLC will be enrolled at the center whose Principal Investigator is the scientific coordinator.
These are patients with unresectable NSCLC who are not eligible for surgery and whose initial treatment consists of medical therapy (chemotherapy and/or immunotherapy).
The samples are obtained using non-invasive techniques (mostly CT-guided biopsy and, less frequently, bronchoscopic or esophageal endoscopic biopsy).
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The procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples. The protocol-mandated tumor sampling at progression will be performed in the following two situations:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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"The primary objective is to assess the association between the immune signature in peripheral blood and the efficacy of immunotherapies in patients with advanced-stage NSCLC
Prazo: until the patient's death"or until the end of the patient follow-up period, which is 60 months
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Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.
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until the patient's death"or until the end of the patient follow-up period, which is 60 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients
Prazo: through study completion, an average of 7 year
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Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC
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through study completion, an average of 7 year
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Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC
Prazo: through study completion, an average of 7 year
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Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC
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through study completion, an average of 7 year
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Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC
Prazo: through study completion, an average of 7 year
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Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC
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through study completion, an average of 7 year
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Study the HVEM/BTLA axis in localized and advanced NSCLC
Prazo: through study completion, an average of 7 year
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Association between HVEM expression and overall survival in localized and advanced NSCLC
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through study completion, an average of 7 year
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Analyze co-signaling molecules, activating receptors, inhibitory receptors, as well as the maturation, exhaustion, and proliferation of anti-tumor immune cells, and cytokines
Prazo: through study completion, an average of 7 year
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Percentage expression of co-signaling molecules, activating receptors, inhibitory receptors, as well as maturation, exhaustion, and proliferation markers of anti-tumor immune cells by mass cytometry (Appendix 1).
Percentage expression of inflammatory cytokines by Luminex
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through study completion, an average of 7 year
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Analyze the impact of the tumor and its microenvironment on the phenotype of anti-tumor immune cells
Prazo: through study completion, an average of 7 year
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Levels of immune response in organoid cultures
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through study completion, an average of 7 year
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IMMUNOLUNG-IPC 2021-069
- 2025-A00769-40 (Identificador de registro: Numéro ID RCB)
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