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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Thomas Winder, MD, PhD
- Numero di telefono: +43 5522 3032694
- Email: Thomas.Winder@vlkh.at
Backup dei contatti dello studio
- Nome: Axel Muendlein, PhD
- Numero di telefono: +43 5572 3726581
- Email: axel.muendlein@vivit.at
Luoghi di studio
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Vorarlberg
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Bregenz, Vorarlberg, Austria, 6900
- Reclutamento
- Landeskrankenhaus Bregenz
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Contatto:
- Claudius Falch, MD
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Feldkirch, Vorarlberg, Austria, 6800
- Reclutamento
- Landeskrankenhaus Feldkirch
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Contatto:
- Jürgen Parzefall, MD
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Contatto:
- Markus Weigl, MD
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Hohenems, Vorarlberg, Austria, 6845
- Attivo, non reclutante
- Landeskrankenhaus Hohenems
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Rankweil, Vorarlberg, Austria, 6830
- Attivo, non reclutante
- Landeskrankenhaus Rankweil
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Survival (OS)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Disease-Free Survival (DFS)
Lasso di tempo: 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
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Progression-Free Survival (PFS)
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Thomas Winder, MD, PhD, Landeskrankenhaus Feldkirch
- Direttore dello studio: Axel Muendlein, PhD, Vorarlberg Institute for Vascular Investigation and Treatment
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DK-24-05-2023
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
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