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

September 8, 2022 updated by: Amgen
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
439

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

  • Belgium
      • Bonheiden, Belgium, 2820
        • Research Site
      • Brasschaat, Belgium, 2930
        • Research Site
      • Brugge, Belgium, 8000
        • Research Site
      • Haine Saint Paul - La Louviere, Belgium, 7100
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Merksem, Belgium, 2170
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Chomutov, Czechia, 430 12
        • Research Site
      • Jihlava, Czechia, 586 01
        • Research Site
      • Plzen, Czechia, 304 60
        • Research Site
      • Praha 4, Czechia, 140 59
        • Research Site
      • Usti nad Labem, Czechia, 401 13
        • Research Site
  • Denmark
      • Esbjerg, Denmark, 6700
        • Research Site
      • Herning, Denmark, 7400
        • Research Site
      • Hillerod, Denmark, 3400
        • Research Site
      • København, Denmark, 2100
        • Research Site
  • France
      • Ajaccio, France, 20176
        • Research Site
      • Avignon, France, 84000
        • Research Site
      • Bordeaux Cedex, France, 33030
        • Research Site
      • Brest, France, 29200
        • Research Site
      • Clermont Ferrand cedex 1, France, 69003
        • Research Site
      • Evry cedex, France, 91035
        • Research Site
      • Grenoble Cedex 9, France, 38043
        • Research Site
      • La Tronche, France, 38700
        • Research Site
      • Limoges Cedex 1, France, 87039
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
      • Marseille Cedex 08, France, 13285
        • Research Site
      • Muret Cedex, France, 31605
        • Research Site
      • Nancy, France, 54100
        • Research Site
      • Perpignan, France, 66000
        • Research Site
      • Périgueux cedex, France, 24004
        • Research Site
      • Reims, France, 51092
        • Research Site
      • Saint Grégoire cedex, France, 35768
        • Research Site
      • Strasbourg, France, 67000
        • Research Site
      • Toulouse, France, 31076
        • Research Site
  • Germany
      • Ahaus, Germany, 48683
        • Research Site
      • Amberg, Germany, 92224
        • Research Site
      • Arnsberg, Germany, 59759
        • Research Site
      • Aschersleben, Germany, 06449
        • Research Site
      • Bonn, Germany, 53123
        • Research Site
      • Dessau, Germany, 06847
        • Research Site
      • Duisburg, Germany, 47051
        • Research Site
      • Frankfurt am Main, Germany, 60590
        • Research Site
      • Goslar, Germany, 38642
        • Research Site
      • Halle (Saale), Germany, 06097
        • Research Site
      • Hamburg, Germany, 20095
        • Research Site
      • Köln, Germany, 50677
        • Research Site
      • Köln, Germany, 51103
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Leverkusen, Germany, 51375
        • Research Site
      • München, Germany, 80335
        • Research Site
      • München, Germany, 81925
        • Research Site
      • München, Germany, 80638
        • Research Site
      • Osnabrück, Germany, 49076
        • Research Site
      • Pforzheim, Germany, 75179
        • Research Site
      • Recklinghausen, Germany, 45657
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
      • Saarbrücken, Germany, 66113
        • Research Site
      • Wilhelmshaven, Germany, 26389
        • Research Site
  • Italy
      • Foggia, Italy, 71100
        • Research Site
      • Legnago VR, Italy, 37045
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Ravenna, Italy, 48100
        • Research Site
      • Roma, Italy, 00189
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Vimercate MB, Italy, 20871
        • Research Site
  • Netherlands
      • Amstelveen, Netherlands, 1186 AM
        • Research Site
      • Doetinchem, Netherlands, 7009 BL
        • Research Site
      • Eindhoven, Netherlands, 5623 EJ
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Research Site
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07198
        • Research Site
    • Castilla León
      • Burgos, Castilla León, Spain, 09006
        • Research Site
    • Cataluña
      • Granollers, Cataluña, Spain, 08402
        • Research Site
    • Comunidad Valenciana
      • Castellon, Comunidad Valenciana, Spain, 12002
        • Research Site
    • Galicia
      • Ourense, Galicia, Spain, 32005
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Research Site
    • País Vasco
      • Bilbao, País Vasco, Spain, 48013
        • Research Site
  • Sweden
      • Eskilstuna, Sweden, 631 88
        • Research Site
      • Göteborg, Sweden, 416 85
        • Research Site
      • Karlskrona, Sweden, 378 85
        • Research Site
      • Skövde, Sweden, 541 85
        • Research Site
      • Västerås, Sweden, 721 89
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of oncologists who agree to participate in the study
Time Frame: 3 years
3 years
The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix
Time Frame: 3 years
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
Time Frame: 3 years
The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.
3 years
The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method
Time Frame: 3 years
The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.
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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20101120

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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