Colorectal NeoplasmsNCT07913802
Prospective Multicenter Cohort Study of Clinical and Molecular Biomarkers in Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Vorarlberg Institute for Vascular Investigation and Treatment at 4 sites in Austria.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 200 participants
- Where
- 4 sitesAustria
- Study dates
- 23 Oct 2023to Oct 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years.
- Histologically confirmed colorectal carcinoma.
- Planned surgical resection of the primary colorectal tumor.
- Written informed consent to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria4 sites, 2 recruiting
- Recruiting
Landeskrankenhaus Bregenz
Bregenz, Vorarlberg, 6900
Claudius Falch, MD
- Recruiting
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, 6800
Jürgen Parzefall, MD
Markus Weigl, MD
- Active, not recruiting
Landeskrankenhaus Hohenems
Hohenems, Vorarlberg, 6845
- Active, not recruiting
Landeskrankenhaus Rankweil
Rankweil, Vorarlberg, 6830
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Colorectal Neoplasms
- Keywords
- Longitudinal Biobanking, Prognostic Biomarkers, Predictive Biomarkers, Liquid Biopsy, Tumor Tissue, Circulating Tumor DNA, Molecular Profiling, Disease Recurrence, Progression Free Survival, Overall Survival
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
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.
Measured: Up to 5 years after surgical resection
Secondary outcomes (2)
Disease-Free Survival (DFS)
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.
Measured: Up to 5 years after surgical resection
Progression-Free Survival (PFS)
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.
Measured: Up to 5 years after surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start23 Oct 2023
- Primary completionOct 2028 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vorarlberg Institute for Vascular Investigation and Treatment
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Winder, MD, PhD, Principal investigator, Landeskrankenhaus FeldkirchAxel Muendlein, PhD, Study director, Vorarlberg Institute for Vascular Investigation and Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913802
- Sponsor's protocol ID
- DK-24-05-2023
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07913802
- Acronym / sponsor ID
- DK-24-05-2023
- Conditions
- Colorectal Neoplasms
- Keywords
- Longitudinal Biobanking, Prognostic Biomarkers, Predictive Biomarkers, Liquid Biopsy, Tumor Tissue, Circulating Tumor DNA, Molecular Profiling, Disease Recurrence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vorarlberg Institute for Vascular Investigation and TreatmentUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Histologically confirmed colorectal carcinoma.
- Planned surgical resection of the primary colorectal tumor.
- Written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: 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.
2 secondary outcomes
Disease-Free Survival (DFS)
Time frame: Up to 5 years after surgical resection
Progression-Free Survival (PFS)
Time frame: Up to 5 years after surgical resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Winder, MD, PhD principal investigator
Landeskrankenhaus Feldkirch
Axel Muendlein, PhD study director
Vorarlberg Institute for Vascular Investigation and Treatment
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Vorarlberg Institute for Vascular Investigation and Treatment at 4 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Winder, MD, PhD (+43 5522 3032694, Thomas.Winder@vlkh.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 5 years after surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.