A Population-based Prospective Study of Metastatic Colorectal Cancer (CRC) Patients in Finland

Study Overview
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Brief Summary
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A population-based prospective study to evaluate clinical behaviour, resectability and survival in 1st line metastatic colorectal cancer (CRC) patients in Finland Primary objective: To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy and targeted drugs with overall response rates (ORR), failure free survival (FFS), progression free survival (PFS), and overall survival (OS); To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and tumour block biomarkers and DNA polymorphisms that may predict drug effects, resectability and clinical behaviour of the tumour

Official Title
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A Population-based Prospective Study to Evaluate Clinical Behaviour, Resectability and Survival in 1st Line Metastatic Colorectal Cancer (CRC) Patients in Finland

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Other: Biomarker sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease Age > 18 Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy) Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to study No informed consent will be obtained from patients participating in the data collection study obtaining data from hospital charts. No blood sampling, nor contacting of patients will be performed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mCRC treatments<br>All used treatments for metastatic colorectal cancer | Other: Biomarker sampling<br>* Blood samples every 8-12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectability | To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Response rates | 5 years | 
| Safety | Number of adverse events | 5 years | 
| Radiological assessment | To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic colorectal cancer