- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935763
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
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Buenos Aires, Argentina
- Instituto de Oncología Angel H. Roffo
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Salzburg, Austria, 5020
- Landeskrankenhaus-Universitaetsklinik
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Edegem, Belgium
- Antwerp University Hospital
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Zagreb, Croatia
- Klinicki Bolnicki Centar (KBC) Zagreb
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Hradec Králové, Czechia
- University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy
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Paris, France, 75013
- Groupe Hospitalier Pitie Salpetriere
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Wolfsburg, Germany
- Klinikum Wolfsburg
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Heraklion, Greece
- University Hospital of Heraklion
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Budapest, Hungary
- Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely
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Dublin, Ireland
- The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital
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Reggio Emilia, Italy, 42123
- Arcispedale Santa Maria Nuova
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Utrecht, Netherlands, 3584 CX
- UMC Utrecht
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Lisboa, Portugal
- Centro Des Estudos Egas Moniz - Hospital Santa Maria
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Ljubljana, Slovenia
- Institute of Oncology Ljubljana
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Madrid, Spain
- Hospital Universitario 12 de Octubre
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Västerås, Sweden
- Vasteras Central Hospital
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Zürich, Switzerland
- UniversitaetsSpital Zuerich (University Hospital Zurich)
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Manchester, United Kingdom
- Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust
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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 |
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Overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 24 months months
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metastatic Colorectal Cancer (mCRC) overall survival in real world setting
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From date of randomization until the date of death from any cause, assessed up to 24 months months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Disease control measured by overall response
Time Frame: within 18 months from enrollment
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Overall response to treatment defined by complete and partial response, stable disease, progression of the disease
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within 18 months from enrollment
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Quality of life using Patients Reported Outcomes
Time Frame: within 18 months from enrollment
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Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT)
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within 18 months from enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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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