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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT01791361
Collaborator
(none)
439
Enrollment
84
Locations
33
Duration (Months)
5.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Other

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
439 participants
Time Perspective:
Retrospective
Official Title:
Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Round 1

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

Other: Other
No intervention other than routine medical care
Other Names:
  • Medical Records Review

    		•
    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: Other
    No intervention other than routine medical care
    Other Names:
  • Medical Records Review

    		•
    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: Other
    No intervention other than routine medical care
    Other Names:
  • Medical Records Review

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [3 years]

      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

    Secondary Outcome Measures

    1. The proportion of oncologists who agree to participate in the study [3 years]

    2. The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix [3 years]

    3. 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 study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.

    4. The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method [3 years]

      The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.

    5. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Physician 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

    Physician 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

    Patient Inclusion Criteria

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Bonheiden Belgium 2820
    2 Research Site Brasschaat Belgium 2930
    3 Research Site Brugge Belgium 8000
    4 Research Site Haine St. Paul - La Louviere Belgium 7100
    5 Research Site Liège Belgium 4000
    6 Research Site Merksem Belgium 2170
    7 Research Site Brno Czech Republic 656 53
    8 Research Site Chomutov Czech Republic 430 12
    9 Research Site Jihlava Czech Republic 586 01
    10 Research Site Plzen Czech Republic 304 60
    11 Research Site Praha 4 Czech Republic 140 59
    12 Research Site Usti nad Labem Czech Republic 401 13
    13 Research Site Esbjerg Denmark 6700
    14 Research Site Herning Denmark 7400
    15 Research Site Hillerod Denmark 3400
    16 Research Site København Denmark 2100
    17 Research Site Ajaccio France 20176
    18 Research Site Avignon France 84000
    19 Research Site Bordeaux Cedex France 33030
    20 Research Site Brest France 29200
    21 Research Site Clermont Ferrand cedex 1 France 69003
    22 Research Site Evry cedex France 91035
    23 Research Site Grenoble Cedex 9 France 38043
    24 Research Site La Tronche France 38700
    25 Research Site Limoges Cedex 1 France 87039
    26 Research Site Lyon Cedex 08 France 69373
    27 Research Site Marseille Cedex 08 France 13285
    28 Research Site Muret Cedex France 31605
    29 Research Site Nancy France 54100
    30 Research Site Perpignan France 66000
    31 Research Site Périgueux cedex France 24004
    32 Research Site Reims France 51092
    33 Research Site Saint Grégoire cedex France 35768
    34 Research Site Strasbourg France 67000
    35 Research Site Toulouse France 31076
    36 Research Site Ahaus Germany 48683
    37 Research Site Amberg Germany 92224
    38 Research Site Arnsberg Germany 59759
    39 Research Site Aschersleben Germany 06449
    40 Research Site Bonn Germany 53123
    41 Research Site Dessau Germany 06847
    42 Research Site Duisburg Germany 47051
    43 Research Site Frankfurt am Main Germany 60590
    44 Research Site Goslar Germany 38642
    45 Research Site Halle (Saale) Germany 06097
    46 Research Site Hamburg Germany 20095
    47 Research Site Köln Germany 50677
    48 Research Site Köln Germany 51103
    49 Research Site Leipzig Germany 04103
    50 Research Site Leverkusen Germany 51375
    51 Research Site München Germany 80335
    52 Research Site München Germany 80638
    53 Research Site München Germany 81925
    54 Research Site Osnabrück Germany 49076
    55 Research Site Pforzheim Germany 75179
    56 Research Site Recklinghausen Germany 45657
    57 Research Site Regensburg Germany 93053
    58 Research Site Saarbrücken Germany 66113
    59 Research Site Wilhelmshaven Germany 26389
    60 Research Site Foggia Italy 71100
    61 Research Site Legnago VR Italy 37045
    62 Research Site Napoli Italy 80131
    63 Research Site Ravenna Italy 48100
    64 Research Site Roma Italy 00189
    65 Research Site Torino Italy 10126
    66 Research Site Vimercate MB Italy 20871
    67 Research Site Amstelveen Netherlands 1186 AM
    68 Research Site Doetinchem Netherlands 7009 BL
    69 Research Site Eindhoven Netherlands 5623 EJ
    70 Research Site Oviedo Asturias Spain 33006
    71 Research Site Palma de Mallorca Baleares Spain 07198
    72 Research Site Burgos Castilla León Spain 09006
    73 Research Site Granollers Cataluña Spain 08402
    74 Research Site Castellon Comunidad Valenciana Spain 12002
    75 Research Site Ourense Galicia Spain 32005
    76 Research Site Pamplona Navarra Spain 31008
    77 Research Site Bilbao País Vasco Spain 48013
    78 Research Site Madrid Spain 28041
    79 Research Site Madrid Spain 28046
    80 Research Site Eskilstuna Sweden 631 88
    81 Research Site Göteborg Sweden 416 85
    82 Research Site Karlskrona Sweden 378 85
    83 Research Site Skövde Sweden 541 85
    84 Research Site Västerås Sweden 721 89

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01791361
    Other Study ID Numbers:
    • 20101120
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Oct 26, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Amgen
    Metastatic colorectal cancer
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Oct 26, 2015