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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

  • Clinicaltrials.gov identifier

    NCT03935763

  • Recruitment Status

    Recruiting

  • First Posted

    May 2, 2019

  • Last update posted

    November 16, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Metastatic Colorectal Cancer
  • Intervention/Treatment: Other: observational disease study
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 1000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: January 2023

Outcome Measures

  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. 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
  • 2. 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)

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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.

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

Contacts and Locations

Contacts

Contact: Myriam Koopman +31 88 75 56263 M.Koopman-6@umcutrecht.nl

Locations

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 and Collaborators

Servier Affaires Médicales

More Information

  • Responsible Party: Servier Affaires Médicales
  • ClinicalTrials.gov Identifier: NCT03935763 History of Changes
  • Other Study ID Numbers: DIM-95005-001, EUPAS33865
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: November 16, 2020
  • Last Verified: November 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Servier Affaires Médicales: Real Worl Evidence
  • Additional relevant MeSH terms: Colorectal Neoplasms