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

Recruiting

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: Biomarker sampling

• Registration Number: NCT01531621
• Lead Sponsor: Pia Osterlund

Brief Summary

* 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mCRC treatments	Biomarker sampling	All used treatments for metastatic colorectal cancer

Primary Outcome Measures

Name	Time	Method
Resectability	5 years	To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection

Secondary Outcome Measures

Name	Time	Method
Efficacy	5 years	Response rates
Radiological assessment	5 years	To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria
Safety	5 years	Number of adverse events

Trial Locations

Locations (1)

Department of Oncology; 🇫🇮 Helsinki, Finland