Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Metastatic Colorectal Cancer Clinical Trial

— PROMETCO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03935763
• Other study ID #: DIM-95005-001
• Secondary ID: EUPAS33865
• Status: Active, not recruiting
• Start date: March 8, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 738
• Est. completion date: November 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• observational disease study
observation of routine clinical practices in mCRC

Locations

Country	Name	City	State
Argentina	Instituto de Oncología Angel H. Roffo	Buenos Aires
Austria	Landeskrankenhaus-Universitaetsklinik	Salzburg
Belgium	Antwerp University Hospital	Edegem
Croatia	Klinicki Bolnicki Centar (KBC) Zagreb	Zagreb
Czechia	University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy	Hradec Králové
France	Groupe Hospitalier Pitié Salpêtrière	Paris
Germany	Klinikum Wolfsburg	Wolfsburg
Greece	University Hospital Of Heraklion	Heraklion
Hungary	Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely	Budapest
Ireland	The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital	Dublin
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Netherlands	UMC Utrecht	Utrecht
Portugal	Centro Des Estudos Egas Moniz - Hospital Santa Maria	Lisboa
Slovenia	Institute Of Oncology Ljubljana	Ljubljana
Spain	Hospital Universitario 12 de Octubre	Madrid
Sweden	Vasteras Central Hospital	Västerås
Switzerland	UniversitaetsSpital Zuerich (University Hospital Zurich)	Zürich
United Kingdom	Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Servier Affaires Médicales

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Croatia,  Czechia,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Netherlands,  Portugal,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	metastatic Colorectal Cancer (mCRC) overall survival in real world setting	From date of randomization until the date of death from any cause, assessed up to 24 months months
Secondary	Disease control measured by overall response	Overall response to treatment defined by complete and partial response, stable disease, progression of the disease	within 18 months from enrollment
Secondary	Quality of life using Patients Reported Outcomes	Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT)	within 18 months from enrollment