- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07557849
Multicentric Database for KRAS Mutant Pancreatic Cancer
Construction and Maintenance of a Precision Subtyping-Based Clinical Cohort for Targeted Therapy in KRAS-Mutant Pancreatic Cancer
Visão geral do estudo
Status
Condições
Descrição detalhada
Pancreatic cancer is one of the most aggressive tumors in the digestive system, often referred to as the "king of cancers". Globally, its incidence and mortality rank 12th and 7th among all malignant tumors. According to the American Cancer Society, pancreatic cancer is projected to become the second leading cause of cancer-related death in the US by 2030.
KRAS gene mutations are the most common genetic alterations in pancreatic cancer, occurring in approximately 90% of patients, with subtypes such as G12D, G12V, and G12R being particularly prevalent. Conventional chemotherapy and radiotherapy offer limited efficacy and are associated with significant side effects.
With advances in precision medicine, targeted therapy has emerged as a promising treatment strategy. Substantial progress has been made in developing KRAS-targeted drugs, some of which have entered clinical trials and shown encouraging results. However, due to the complexity and heterogeneity of KRAS mutations, patient responses to targeted therapy vary significantly. Therefore, it is essential to establish a prospective cohort study to comprehensively evaluate the efficacy and safety of KRAS-targeted therapies and inform clinical decision-making.
We aim to construct a clinical cohort for KRAS-mutant pancreatic cancer patients undergoing targeted therapy, with the goal of building a database system aligned with both clinical practice and research needs. This study consists of two components:
- Designing and implementing a database tailored to real-world clinical scenarios, retrospectively collecting clinical data from pancreatic tumor patients treated at the Shanghai Pancreatic Cancer Institute and multiple domestic and international centers, thereby establishing a real-world evidence (RWE) database;
- Prospectively collecting clinical information from pancreatic cancer patients treated at the same institutions, with regular updates and maintenance of the pancreatic tumor RWE database.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Yi Liu, MD
- Número de telefone: 86 21-64175590
- E-mail: liuyi@fudanpci.org
Locais de estudo
-
-
-
Shanghai, China, 200032
- Recrutamento
- Department of Pancreatic Surgery
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
This study is a multicenter real-world data collection research . It aims to establish a multicenter real-world evidence (RWE) database for KRAS-targeted therapy in pancreatic cancer. The study will retrospectively collect clinical data of pancreatic cancer patients with KRAS mutations previously diagnosed and treated at the Shanghai Pancreatic Cancer Institute , and prospectively collect clinical information from similar patients treated at the same institute. The database will be regularly updated and maintained.
Clinical data of KRAS-mutant pancreatic cancer patients from domestic and international pancreatic tumor centers will be collected and periodically updated. Identifiable personal information such as ID numbers and names will be removed to enable multicenter collaboration and ensure patient privacy, with the goal of generating reliable evidence-based medical data .
Descrição
Inclusion Criteria:
No restrictions on age, gender, or performance status score;
Pathologically or cytologically confirmed pancreatic adenocarcinoma; ③ Known KRAS mutation subtype and has received treatment with KRAS-targeted agents;
④ Able to comply with the study visit schedule requirements;
⑤ Voluntarily participate and sign the informed consent form.
Exclusion Criteria:
Non-neoplastic pancreatic lesions;
- Non-primary pancreatic neoplastic lesions; ③ Unable to comply with the study visit schedule requirements; ④ Refuse to participate and sign the informed consent form.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Pancreatic cancer with KRAS mutation
Patients with pancreatic cancer with KRAS mutation who received KRAS targeted therapy
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall survival
Prazo: 12 months
|
OS: OS of subjects from recruiting to the time of death from any cause
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression free survival (PFS)
Prazo: up to 10 years
|
Progression free survival (PFS) is calculated from the date of starting KRAS targted therapy and ends when the first event (progression/death) occurs.
|
up to 10 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guopei Luo, Fudan University
Publicações e links úteis
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
- PTCA199-17
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Tipo de informação de suporte de compartilhamento de IPD
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .