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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03935763
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Servier ( Servier Affaires Médicales )

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

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Other: observational disease study

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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 8, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

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


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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935763


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

Locations
Show Show 18 study locations
Sponsors and Collaborators
Servier Affaires Médicales

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Responsible Party: Servier Affaires Médicales
ClinicalTrials.gov Identifier: NCT03935763    
Other Study ID Numbers: DIM-95005-001
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servier ( Servier Affaires Médicales ):
Real Worl Evidence
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases