Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe (20101120)

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

Observational Research Study Report 20101120 - Abstract