Study type

Study topic

Disease /health condition
Human medicinal product
Other

Study topic, other

Diagnostic procedure - KRAS testing

Study type

Non-interventional study

Scope of the study

Drug utilisation
Other

If ‘other’, further details on the scope of the study

Describe patterns of KRAS biomarker testing prior to initiating treatment

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Name of medicine

VECTIBIX

Medical condition to be studied

Colorectal cancer metastatic
Population studied

Short description of the study population

Patients with metastatic colorectal cancer (mCRC) treated with Vectibix following the changes of label about the risk of Vectibix use in mCRC patients with mutant KRAS tumors in selected European countries.
Patients who had received Vectibix for the treatment of mCRC during the 6-month period prior to the time when medical records were obtained, not have been in any experimental clinical trial at time of receiving Vectibix, and not have participated in this study, in an earlier round were included.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Colorectal cancer patients

Estimated number of subjects

450
Study design details

Main study objective

This non-interventional cross-sectional medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix over 3 rounds. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

Outcomes

The prevalence of KRAS testing and impact of the KRAS test results on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix Timeframe: 3 Years, The proportion of oncologists who participate in the study. The proportion of oncologists who conduct a KRAS test prior to initiating Vectibix treatment. The proportion of labs that are part of an European Society of Pathology Quality Assurance scheme. The proportion of labs that use a validated KRAS testing method. To assess the change in pattern of Vectibix administation over the 3 rounds.

Data analysis plan

Analysis will be conducted on 3 levels - patient level, oncologist level and laboratory level. Descriptive statistics will be calculated at each level.
Documents
Study results
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