Metastatic Colorectal Cancer
Conditions
Keywords
Real Worl Evidence
Brief summary
A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
Interventions
OTHERobservational disease study
observation of routine clinical practices in mCRC
Sponsors
Servier Affaires Médicales
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Diagnosis of mCRC * Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment.
Exclusion criteria
* Currently participating in an investigational clinical trial (thus it 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of randomization until the date of death from any cause, assessed up to 24 months months | metastatic Colorectal Cancer (mCRC) overall survival in real world setting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control measured by overall response | within 18 months from enrollment | Overall response to treatment defined by complete and partial response, stable disease, progression of the disease |
| Quality of life using Patients Reported Outcomes | within 18 months from enrollment | Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT) |
Countries
Argentina, Austria, Belgium, Croatia, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Portugal, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed