Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective (PROMETCO)

April 19, 2024 updated by: Servier Affaires Médicales

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

738

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Instituto de Oncología Ángel H. Roffo
  • Austria
      • Salzburg, Austria, 5020
        • Landeskrankenhaus-Universitaetsklinik
  • Belgium
      • Edegem, Belgium
        • Antwerp University Hospital
  • Croatia
      • Zagreb, Croatia
        • Klinicki Bolnicki Centar (KBC) Zagreb
  • Czechia
      • Hradec Králové, Czechia
        • University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy
  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitié Salpêtrière
  • Germany
      • Wolfsburg, Germany
        • Klinikum Wolfsburg
  • Greece
      • Heraklion, Greece
        • University Hospital of Heraklion
  • Hungary
      • Budapest, Hungary
        • Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely
  • Ireland
      • Dublin, Ireland
        • The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital
  • Italy
      • Reggio Emilia, Italy, 42123
        • Arcispedale Santa Maria Nuova
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
  • Portugal
      • Lisboa, Portugal
        • Centro Des Estudos Egas Moniz - Hospital Santa Maria
  • Slovenia
      • Ljubljana, Slovenia
        • Institute of Oncology Ljubljana
  • Spain
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
  • Sweden
      • Västerås, Sweden
        • Västerås Central Hospital
  • Switzerland
      • Zürich, Switzerland
        • UniversitaetsSpital Zuerich (University Hospital Zurich)
  • United Kingdom
      • Manchester, United Kingdom
        • Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
From date of randomization until the date of death from any cause, assessed up to 24 months months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control measured by overall response
Time Frame: within 18 months from enrollment
Overall response to treatment defined by complete and partial response, stable disease, progression of the disease
within 18 months from enrollment
Quality of life using Patients Reported Outcomes
Time Frame: within 18 months from enrollment
Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT)
within 18 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Affaires Médicales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIM-95005-001
  • EUPAS33865 (Other Identifier: EU PAS Register Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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