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

Pia Osterlund1,000 enrolled

Overview

* 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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Metastatic Colorectal Cancer

Interventions

Biomarker samplingOTHER

Blood samples every 8-12 weeks

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease 2. Age \> 18 3. Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy) 4. 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 5. 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.

Outcomes

Primary Outcomes

Resectability

To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection

Time frame: 5 years

Secondary Outcomes

Efficacy

Response rates

Time frame: 5 years

Safety

Number of adverse events

Time frame: 5 years

Radiological assessment

To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria

Time frame: 5 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts