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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Thomas Winder, MD, PhD
- Telefonnummer: +43 5522 3032694
- E-Mail: Thomas.Winder@vlkh.at
Studieren Sie die Kontaktsicherung
- Name: Axel Muendlein, PhD
- Telefonnummer: +43 5572 3726581
- E-Mail: axel.muendlein@vivit.at
Studienorte
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Vorarlberg
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Bregenz, Vorarlberg, Österreich, 6900
- Rekrutierung
- Landeskrankenhaus Bregenz
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Kontakt:
- Claudius Falch, MD
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Feldkirch, Vorarlberg, Österreich, 6800
- Rekrutierung
- Landeskrankenhaus Feldkirch
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Kontakt:
- Jürgen Parzefall, MD
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Kontakt:
- Markus Weigl, MD
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Hohenems, Vorarlberg, Österreich, 6845
- Aktiv, nicht rekrutierend
- Landeskrankenhaus Hohenems
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Rankweil, Vorarlberg, Österreich, 6830
- Aktiv, nicht rekrutierend
- Landeskrankenhaus Rankweil
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Overall Survival (OS)
Zeitfenster: Up to 5 years after surgical resection
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Disease-Free Survival (DFS)
Zeitfenster: 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)
Zeitfenster: Up to 5 years after surgical resection
|
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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Thomas Winder, MD, PhD, Landeskrankenhaus Feldkirch
- Studienleiter: Axel Muendlein, PhD, Vorarlberg Institute for Vascular Investigation and Treatment
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DK-24-05-2023
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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