Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Name of medicine

VECTIBIX

Medical condition to be studied

Skin toxicity
Population studied

Short description of the study population

Patients needed to be at least 18 years of age, have a diagnosis of metastatic colorectal cancer (mCRC) and provide consent to participate.
Inclusion Criteria
1. 18 years of age or older
2. Have a self-reported physician diagnosis of mCRC
3. Have consented to participate
Exclusion Criteria
Patients not meeting inclusion criteria will be excluded. Additional exclusion criteria include treatment with cetuximab at any point.

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

Metastatic colorectal cancer (mCRC) patients

Estimated number of subjects

200
Study design details

Main study objective

To assess the experiences and opinions regarding dermatologic toxicities that may develop among mCRC patients who are treated with and without Vectibix.

Outcomes

Among mCRC Vectibix patients• Describe mCRC patient opinions regarding the risk of skin • Characterize the timing and severity of rash • Describe the education they received to prevent and manage rash • Describe management strategies • Describe the impact on quality of lifeAmong mCRC non-Vectibix patients • Describe patient opinions regarding the risk of skin rash

Data analysis plan

The following descriptive statistics will be analyzed:• Proportion of mCRC patients who agree to participate in the study• Proportion of mCRC patients who meet the criteria for participation (i.e. eligibility rate)The consent rate will be calculated as the proportion of eligible patients who consent to participate in the survey out of all eligible patients.
Documents
Study results
English (38.69 KB - PDF)View document