Clinical trial NCT03935763: Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
Official title: A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Colorectal Cancer
Keywords: Real Worl Evidence
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population will be adults with mCRC who are eligible and willing to receive subsequent treatment, having had two prior progressions since diagnosis of first metastasis.

Brief summary: A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 24 months months
Secondary outcomes:
measure: Disease control measured by overall response
timeFrame: within 18 months from enrollment
measure: Quality of life using Patients Reported Outcomes
timeFrame: within 18 months from enrollment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto de Oncología Angel H. Roffo
city: Salzburg
country: Austria
facility: Landeskrankenhaus-Universitaetsklinik
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Zagreb
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Zagreb
city: Hradec Králové
country: Czechia
facility: University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
city: Wolfsburg
country: Germany
facility: Klinikum Wolfsburg
city: Heraklion
country: Greece
facility: University Hospital Of Heraklion
city: Budapest
country: Hungary
facility: Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely
city: Dublin
country: Ireland
facility: The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Lisboa
country: Portugal
facility: Centro Des Estudos Egas Moniz - Hospital Santa Maria
city: Ljubljana
country: Slovenia
facility: Institute Of Oncology Ljubljana
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Västerås
country: Sweden
facility: Vasteras Central Hospital
city: Zürich
country: Switzerland
facility: UniversitaetsSpital Zuerich (University Hospital Zurich)
city: Manchester
country: United Kingdom
facility: Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust
Study officials:
References:
citation: Koopman M, Pinto C, Bodoky G, Garcia-Carbonero R, Marti FM, Bachet JB. Rationale and design of the PROMETCO study: a real-world, prospective, longitudinal cohort on the continuum of care of metastatic colorectal cancer from a clinical and patient perspective. Future Oncol. 2022 Apr;18(11):1313-1320. doi: 10.2217/fon-2021-1333. Epub 2022 Jan 19.