Prospective Multicenter Cohort Study of Clinical and Molecular Biomarkers in Colorectal Cancer
Prospective Cohort Study to Investigate Clinical Factors and Molecular Biomarkers Associated With Treatment Response and Disease Outcomes in Patients With Colorectal Cancer in Vorarlberg, Austria
This prospective, multicenter observational study aims to identify clinical and molecular biomarkers associated with treatment response, disease recurrence, progression, and survival in patients with colorectal cancer (CRC).
Approximately 200 adult patients undergoing surgical resection for CRC will be enrolled and followed for up to five years. Tumor tissue and blood samples will be collected for molecular analyses, and clinical data will be recorded longitudinally to investigate associations between biomarkers and disease outcomes.
All treatment decisions will follow standard clinical practice and will not be influenced by study participation.
Visão geral do estudo
Status
Condições
Descrição detalhada
Colorectal cancer is a heterogeneous disease characterized by substantial variability in tumor biology, treatment response, and clinical outcomes. The identification of reliable molecular biomarkers may improve risk stratification, facilitate the detection of disease recurrence, and support the development of personalized treatment strategies.
This prospective, multicenter observational cohort study aims to establish a longitudinal biobank of biological specimens linked to comprehensive clinical data from patients with colorectal cancer undergoing surgical treatment.
Biological specimens, including tumor tissue, adjacent non-malignant tissue, and peripheral blood, will be collected and stored for molecular and biochemical investigations. Serial blood sampling during follow-up will enable the investigation of longitudinal changes in circulating biomarkers and their potential association with disease progression, treatment response, and clinical outcomes.
Planned research activities include molecular characterization of tumor tissue, analysis of circulating tumor DNA (ctDNA), investigation of tumor-associated genetic alterations, gene expression profiling, and measurement of circulating biomarkers. Where feasible, patient-derived tumor cells may also be isolated and cultured for exploratory investigations.
Clinical information, including tumor characteristics, treatment modalities, and disease course, will be documented prospectively and linked to the collected biological specimens. This integrated approach will enable the investigation of associations between molecular characteristics, longitudinal biomarker dynamics, and clinical outcomes.
The study is intended to provide a comprehensive research resource for identifying and validating prognostic and predictive biomarkers in colorectal cancer. All diagnostic and therapeutic decisions will be made according to routine clinical practice and will not be influenced by study participation.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Thomas Winder, MD, PhD
- Número de telefone: +43 5522 3032694
- E-mail: Thomas.Winder@vlkh.at
Estude backup de contato
- Nome: Axel Muendlein, PhD
- Número de telefone: +43 5572 3726581
- E-mail: axel.muendlein@vivit.at
Locais de estudo
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Vorarlberg
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Bregenz, Vorarlberg, Áustria, 6900
- Recrutamento
- Landeskrankenhaus Bregenz
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Contato:
- Claudius Falch, MD
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Feldkirch, Vorarlberg, Áustria, 6800
- Recrutamento
- Landeskrankenhaus Feldkirch
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Contato:
- Jürgen Parzefall, MD
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Contato:
- Markus Weigl, MD
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Hohenems, Vorarlberg, Áustria, 6845
- Ativo, não recrutando
- Landeskrankenhaus Hohenems
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Rankweil, Vorarlberg, Áustria, 6830
- Ativo, não recrutando
- Landeskrankenhaus Rankweil
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population consists of adult patients (aged 18 years or older) diagnosed with colorectal cancer who undergo surgical resection at participating hospitals in Vorarlberg, Austria. Patients will be consecutively recruited irrespective of tumor stage (UICC I-IV) or planned neoadjuvant or adjuvant treatment. All participants must provide written informed consent. Clinical data and biological samples will be collected prospectively, and patients will be followed for up to five years after surgery.
Descrição
Inclusion Criteria:
- Age ≥18 years.
- Histologically confirmed colorectal carcinoma.
- Planned surgical resection of the primary colorectal tumor.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Age <18 years.
- Pregnancy.
- Individuals held in custody by order of a court or public authority.
- Known current alcohol and/or illicit drug abuse that, in the investigator's judgment, may compromise participant safety and/or compliance.
- Inability to understand and sign the informed consent form.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: Up to 5 years after surgical resection
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Overall survival (OS) is defined as the time from surgical resection of colorectal cancer to death from any cause. Patients who are alive at the end of the follow-up period will be censored at the date they were last known to be alive. |
Up to 5 years after surgical resection
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Disease-Free Survival (DFS)
Prazo: Up to 5 years after surgical resection
|
Disease-free survival (DFS) is defined as the time from achievement of a disease-free state following curative-intent treatment to the first documented recurrence of colorectal cancer or death from any cause, whichever occurs first. DFS will be assessed in patients with no evidence of residual disease following treatment, including patients with completely resected metastatic disease. Patients without an event will be censored at the date of their last available disease assessment. |
Up to 5 years after surgical resection
|
|
Progression-Free Survival (PFS)
Prazo: Up to 5 years after surgical resection
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Progression-free survival (PFS) is defined as the time from surgical resection to the first documented disease progression or death from any cause, whichever occurs first. PFS will be assessed in patients with residual or metastatic colorectal cancer following surgery. Patients without an event will be censored at the date of their last available disease assessment. |
Up to 5 years after surgical resection
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Thomas Winder, MD, PhD, Landeskrankenhaus Feldkirch
- Diretor de estudo: Axel Muendlein, PhD, Vorarlberg Institute for Vascular Investigation and Treatment
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
- DK-24-05-2023
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
No formal plan for sharing individual participant data (IPD) with external researchers has been established. Any future data sharing will be subject to applicable data protection regulations, ethical requirements, and appropriate data-sharing agreements. Study results will be published in aggregated form.
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