A Real-World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
Study design
PROMETCO: International, non-interventional, retrospective/prospective,
longitudinal cohort study1,2
738
Patients enrolled
96
Participating sites*
18
Participating countries
*At academic or community-based medical sites experienced in the management of CRC and in conducting observational studies
Participating countries
Enrollment criteria1,2
Which outcomes will be assessed prospectively?1,2
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Treatment patterns
Effectiveness
Safety
Patient-reported outcomes
Healthcare resource utilization
Treatment patterns
• Systemic treatments received (dose and schedule), by line of treatment
• Dose adjustments and discontinuations
Effectiveness
• Response to treatment
• Date of response
• Method used to assess response
• Date of death
Safety
• Adverse events
• Clinical progression
• Abnormal blood tests results
Patient-reported outcomes
• EuroQol-5D (EQ-5D)
• BFI
• Modified ACCEPT© questionnaire
Healthcare resource utilisation
• Hospitalizations
• Emergency room visits
• Outpatient visits
• Hospice care
• Concomitant medications
Inclusion criteria
Adults (aged ≥18 years) with diagnosis of mCRC
Two disease progressions since diagnosis of first metastasis that led to first systemic treatment
Willing to receive subsequent treatment
Willing and able to sign an informed consent form
Exclusion criteria
Currently participating in an investigational clinical trial (does not apply to observational cohort studies)
Currently being treated for other cancer(s)
Not having mental capacity and/or ability to participate in the study
