Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
1 other identifier
observational
439
9 countries
84
Brief Summary
This non-interventional retrospective medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Typical duration for all trials
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2012
CompletedStudy Start
First participant enrolled
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2015
CompletedSeptember 10, 2022
September 1, 2022
2.7 years
June 5, 2012
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prevalence of KRAS testing and impact of the KRAS test results on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix
The proportion of patients with mCRC treated with Vectibix only or treated with Vectibix and concurrently treated with oxaliplatin-containing chemotherapy who received a KRAS test to determine tumor KRAS status prior to treatment with Vectibix, and characterize the results of above testing for KRAS testing: proportion that are mutant, wild-type or unknown but tested
3 years
Secondary Outcomes (5)
The proportion of oncologists who agree to participate in the study
3 years
The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix
3 years
The proportion of laboratories that participate in the European Society of Pathology (ESP) Quality Assurance Scheme or are certified by an ESP approved accreditation body
3 years
The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method
3 years
To characterize the results of KRAS testing in the three rounds of chart abstraction that will be carried out at 0, 12 and 24 months to indicate if there are any differences in results from each of the three rounds
3 years
Study Arms (3)
Round 1
50 oncologists participate in Round 1. At least 3 medical records will be reviewed per oncologist
Round 2
50 oncologists will participate in Round 2. At least 3 medical records will be reviewed per oncologist. Round 2 will occur approximately 12 months after Round 1
Round 3
50 oncologists will participate in Round 3. At least 3 medical records will be reviewed per oncologist. Round 3 will occur approximately 24 months after Round 1
Interventions
No intervention other than routine medical care
Eligibility Criteria
Oncologists satisfying all of the physician eligibility criteria will be eligible to participate in the medical records review study. From each eligible oncologist, medical records from 3 or more patients who satisfy all the patient inclusion criteria will be obtained.
You may qualify if:
- Must be a practicing oncology specialist
- Must treat at least 5 new or continuing patients with metastatic colorectal cancer per quarter
- Must have prescribed Vectibix to treat at least 5 new or continuing patients with metastatic colorectal cancer in the past 6 months
You may not qualify if:
- Must be the only oncologist sampled at the same medical centre for that round of the study
- Must not have taken part in the study previously
- Must have received Vectibix for the treatment of metastatic colorectal cancer during the 6-month period prior to the time when medical records are obtained
- Must not have been in any experimental clinical trial at the time of receiving Vectibix
- Must provide written consent to allow access to their medical records (if local laws require it)
- Must not have taken part in the study before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (84)
Research Site
Bonheiden, 2820, Belgium
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Brasschaat, 2930, Belgium
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Bruges, 8000, Belgium
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Haine Saint Paul - La Louviere, 7100, Belgium
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Liège, 4000, Belgium
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Merksem, 2170, Belgium
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Brno, 656 53, Czechia
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Chomutov, 430 12, Czechia
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Jihlava, 586 01, Czechia
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Pilsen, 304 60, Czechia
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Prague, 140 59, Czechia
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Ústí nad Labem, 401 13, Czechia
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Copenhagen, 2100, Denmark
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Esbjerg, 6700, Denmark
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Herning, 7400, Denmark
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Hillerød, 3400, Denmark
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Ajaccio, 20176, France
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Avignon, 84000, France
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Bordeaux, 33030, France
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Brest, 29200, France
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Clermont-Ferrand, 69003, France
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Évry, 91035, France
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Grenoble, 38043, France
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La Tronche, 38700, France
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Limoges, 87039, France
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Lyon, 69373, France
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Marseille, 13285, France
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Muret, 31605, France
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Nancy, 54100, France
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Perpignan, 66000, France
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Périgueux, 24004, France
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Reims, 51092, France
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Saint-Grégoire, 35768, France
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Strasbourg, 67000, France
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Toulouse, 31076, France
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Ahaus, 48683, Germany
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Amberg, 92224, Germany
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Arnsberg, 59759, Germany
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Aschersleben, 06449, Germany
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Bonn, 53123, Germany
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Cologne, 50677, Germany
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Cologne, 51103, Germany
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Dessau, 06847, Germany
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Duisburg, 47051, Germany
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Frankfurt am Main, 60590, Germany
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Goslar, 38642, Germany
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Halle, 06097, Germany
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Hamburg, 20095, Germany
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Leipzig, 04103, Germany
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Leverkusen, 51375, Germany
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München, 80335, Germany
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München, 80638, Germany
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München, 81925, Germany
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Osnabrück, 49076, Germany
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Pforzheim, 75179, Germany
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Recklinghausen, 45657, Germany
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Regensburg, 93053, Germany
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Saarbrücken, 66113, Germany
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Wilhelmshaven, 26389, Germany
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Foggia, 71100, Italy
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Legnago VR, 37045, Italy
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Napoli, 80131, Italy
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Ravenna, 48100, Italy
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Roma, 00189, Italy
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Torino, 10126, Italy
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Vimercate MB, 20871, Italy
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Amstelveen, 1186 AM, Netherlands
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Doetinchem, 7009 BL, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Bilbao, Basque Country, 48013, Spain
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Burgos, Castille and León, 09006, Spain
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Granollers, Catalonia, 08402, Spain
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Ourense, Galicia, 32005, Spain
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Pamplona, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33006, Spain
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Castellon, Valencia, 12002, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Eskilstuna, 631 88, Sweden
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Gothenburg, 416 85, Sweden
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Karlskrona, 378 85, Sweden
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Skövde, 541 85, Sweden
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Västerås, 721 89, Sweden
Related Publications (1)
Han van Krieken J, Kafatos G, Bennett J, Mineur L, Tomasek J, Rouleau E, Fabian P, De Maglio G, Garcia-Alfonso P, Aprile G, Parkar P, Downey G, Demonty G, Trojan J. Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review. BMC Cancer. 2017 Nov 28;17(1):798. doi: 10.1186/s12885-017-3740-4.
PMID: 29183279BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
February 15, 2013
Study Start
September 19, 2012
Primary Completion
June 2, 2015
Study Completion
June 2, 2015
Last Updated
September 10, 2022
Record last verified: 2022-09