- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218801
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program (CLIMB)
May 27, 2022 updated by: European Organisation for Research and Treatment of Cancer - EORTC
This prospective database has two main objectives;
- to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.
- to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
219
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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Innsbruck, Austria, 6020
- Innsbruck Universitaetsklinik
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Vienna, Austria, 1030
- Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
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Gent, Belgium, 9000
- University Hosptial Gent
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Aarhus, Denmark, 8000
- Aarhus University Hospital
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Bordeaux, France, 33076
- Institut Bergonie
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Lyon, France, 69008
- Centre Leon Berard
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Dresden, Germany, 01307
- Universitaetsklinikum Carl Gustav Carus
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Frankfurt Am Main, Germany, 60590
- Klinikum der J.W. Goethe Universitaet
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Milano, Italy, 20141
- Istituto Europeo di Oncologia
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Amsterdam, Netherlands, 1066
- The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
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Leiden, Netherlands, 2300
- Leiden University Medical Centre
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Sremska Kamenica, Serbia, 21204
- Oncology Institute of Vojvodina
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Fuenlabrada, Spain, 28942
- Hospital De Fuenlabrada
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Stockholm, Sweden
- Karolinska University Hospital
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Geneve, Switzerland, 1211
- Hopitaux Universitaires de Geneve - HUG
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Liverpool, United Kingdom, GB L9 7AL
- Aintree University Hospital NHS 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
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline resectable or initially unresectable)
Description
Inclusion Criteria:
- With histologically proven colorectal adenocarcinoma with liver metastasis.
With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).
- Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits.
- Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT.
- Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable
- discussed by a multidisciplinary team before surgery.
- Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.
- With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT.
- Age ≥ 18 years.
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
- Any psychological, familial, or sociological condition potentially hampering understanding of the research project.
- Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Colorectal adenocarcinoma liver metastasis
Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of post-operative complications
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival after 2 years of follow-up
Time Frame: 3 years
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3 years
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Progression free survival at 2 years
Time Frame: 3 years
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3 years
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Number of post-operative complications in the first 50 patients compared to the second 50 patients
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Serge Evrard, Prof., Institut Bergonie
- Study Chair: Graeme Poston, Prof., Aintree University Hospital
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)
May 1, 2015
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
August 7, 2014
First Submitted That Met QC Criteria
August 15, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Actual)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
Other Study ID Numbers
- EORTC-1409-GITCG
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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