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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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 March 10, 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
Show 18 Study Locations
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
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: March 10, 2020
  • Last Verified: March 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