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

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2025

Interventions

  • Other: Biomarker sampling
    • Blood samples every 8-12 weeks

Arms, Groups and Cohorts

  • mCRC treatments
    • All used treatments for metastatic colorectal cancer

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pia Osterlund
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Pia Osterlund, Principal Investigator – Helsinki University Central Hospital
  • Overall Official(s)
    • Pia Osterlund, MD, Principal Investigator, Helsinki University Central Hospital
  • Overall Contact(s)
    • Pia Osterlund, MD, +358-9-4711, pia.osterlund@hus.fi

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