A Real World Evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective (PROMETCO)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Overall survival in real world setting
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  The target population was adults with mCRC who are eligible and willing to receive subsequent; treatment, having had two prior disease progressions since diagnosis of first metastasis.
• 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)
• Estimated number of subjects:
  1000

Study design details

• Study design:
  This was a prospective, observational, non-interventional, international multi-center, cohort study designed to collect data on patients with mCRC after two disease progressions since diagnosis of first metastasis that led to systemic treatment.
• Main study objective:
  To describe the following for mCRC patients in a real world setting:; - Overall survival; - Treatment patterns for mCRC throughout the continuum of care; - Effectiveness/safety of treatments; - Reasons for therapy discontinuations and choice of subsequent treatment; - Adherence to National and European Guidelines; - Healthcare resource utilization; - Patient reported outcomes
• Setting:
  The study was conducted in 18 countries. Investigators at academic or community based medical sites in the selected countries of interest that were experienced in the treatment and management of CRC and in conducting observational studies were approached for potential participation in the study.
• Data analysis plan:
  descriptive statistics
• Summary results:
  This large real world study helped define the current landscape of mCRC patients and therapy, and provided both clinical information and patient reported outcomes for a robust and complete profile of global mCRC management.