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Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

NCT ID: NCT01791361

Last Updated: 2022-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

439 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-19

Study Completion Date

2015-06-02

Brief Summary

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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.

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Detailed Description

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The medical record review will be conducted for 3 rounds in months 0, 12, and 24 after the first medical record abstraction. Before the beginning of the study, a sampling list will be created by Amgen by merging lists of oncologists (and their contact information) to be collected from Cegedim, the ESMO, from major cancer centers and oncology clinics in various countries within Europe. In each round of medical record review, potential participating oncologists will be randomly sampled from all identified oncologists. Potential oncologists will be contacted by letter, telephone or email. The oncologists will be introduced to the study, and their eligibility to participate in the study will be assessed using a standardized questionnaire. The number of oncologists sampled per country will be proportional to the number of oncology centers per country. Approximately 50 oncologists will participate in each round of the study. From each eligible participating oncologist, study staff will then obtain approximately 3 or more medical records for patients who have received Vectibix for the treatment of mCRC during the 6-month period prior to the time of contact with the relevant oncologist and are not involved in an experimental clinical trial when treated with Vectibix. A written consent may be obtained from participating patients to access their medical records, depending on local laws. Medical information will be abstracted from the medical records using standardized forms. Such medical information will include the occurrence and timing of treatment with Vectibix and oxaliplatin-containing chemotherapy, diagnosis of mCRC and the occurrence, timing and results of KRAS testing. The oncologist will also be asked to collect information from the pathology laboratory that performed the KRAS mutation test on the patient, using a standardized pathology data extraction form.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Round 1

50 oncologists participate in Round 1. At least 3 medical records will be reviewed per oncologist

Other

Intervention Type OTHER

No intervention other than routine medical care

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

Other

Intervention Type OTHER

No intervention other than routine medical care

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

Other

Intervention Type OTHER

No intervention other than routine medical care

Interventions

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Other

No intervention other than routine medical care

Intervention Type OTHER

Other Intervention Names

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Medical Records Review

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Bonheiden, , Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Haine Saint Paul - La Louviere, , Belgium

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Liège, , Belgium

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Merksem, , Belgium

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Brno, , Czechia

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Chomutov, , Czechia

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Jihlava, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Ústí nad Labem, , Czechia

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Copenhagen, , Denmark

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Esbjerg, , Denmark

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Herning, , Denmark

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Hillerød, , Denmark

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Ajaccio, , France

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Avignon, , France

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Bordeaux, , France

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Brest, , France

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Clermont-Ferrand, , France

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Évry, , France

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Grenoble, , France

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La Tronche, , France

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Limoges, , France

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Lyon, , France

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Marseille, , France

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Muret, , France

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Nancy, , France

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Perpignan, , France

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Périgueux, , France

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Reims, , France

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Saint-Grégoire, , France

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Strasbourg, , France

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Toulouse, , France

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Ahaus, , Germany

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Amberg, , Germany

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Arnsberg, , Germany

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Aschersleben, , Germany

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Bonn, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Dessau, , Germany

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Duisburg, , Germany

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Frankfurt am Main, , Germany

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Goslar, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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München, , Germany

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München, , Germany

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München, , Germany

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Osnabrück, , Germany

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Pforzheim, , Germany

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Recklinghausen, , Germany

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Regensburg, , Germany

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Saarbrücken, , Germany

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Wilhelmshaven, , Germany

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Foggia, , Italy

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Legnago VR, , Italy

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Napoli, , Italy

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Ravenna, , Italy

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Roma, , Italy

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Torino, , Italy

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Vimercate MB, , Italy

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Amstelveen, , Netherlands

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Doetinchem, , Netherlands

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Eindhoven, , Netherlands

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Palma de Mallorca, Balearic Islands, Spain

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Bilbao, Basque Country, Spain

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Burgos, Castille and León, Spain

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Granollers, Catalonia, Spain

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Ourense, Galicia, Spain

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Pamplona, Navarre, Spain

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Oviedo, Principality of Asturias, Spain

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Castellon, Valencia, Spain

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Madrid, , Spain

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Madrid, , Spain

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Eskilstuna, , Sweden

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Gothenburg, , Sweden

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Karlskrona, , Sweden

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Skövde, , Sweden

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Västerås, , Sweden

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Countries

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Belgium Czechia Denmark France Germany Italy Netherlands Spain Sweden

References

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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.

Reference Type BACKGROUND
PMID: 29183279 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101120

Identifier Type: -

Identifier Source: org_study_id

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