Metastatic Colorectal CancerNCT01791361
Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
An observational study of Metastatic Colorectal Cancer, run by Amgen at 84 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Other
- How many people
- 439 participants
- Where
- 84 sitesin 9 countries
- Study dates
- 19 Sep 2012to 2 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
84 sites in 9 countries.
84 sites in 9 countries
Germany24 sites
Research Site
Ahaus, 48683
Research Site
Amberg, 92224
Research Site
Arnsberg, 59759
Research Site
Aschersleben, 06449
Research Site
Bonn, 53123
Research Site
Cologne, 50677
Research Site
Cologne, 51103
Research Site
Dessau, 06847
Research Site
Duisburg, 47051
Research Site
Frankfurt am Main, 60590
Research Site
Goslar, 38642
Research Site
Halle, 06097
Research Site
Hamburg, 20095
Research Site
Leipzig, 04103
Research Site
Leverkusen, 51375
Research Site
München, 80335
Research Site
München, 80638
Research Site
München, 81925
Research Site
Osnabrück, 49076
Research Site
Pforzheim, 75179
Research Site
Recklinghausen, 45657
Research Site
Regensburg, 93053
Research Site
Saarbrücken, 66113
Research Site
Wilhelmshaven, 26389
France19 sites
Research Site
Ajaccio, 20176
Research Site
Avignon, 84000
Research Site
Bordeaux, 33030
Research Site
Brest, 29200
Research Site
Clermont-Ferrand, 69003
Research Site
Évry, 91035
Research Site
Grenoble, 38043
Research Site
La Tronche, 38700
Research Site
Limoges, 87039
Research Site
Lyon, 69373
Research Site
Marseille, 13285
Research Site
Muret, 31605
Research Site
Nancy, 54100
Research Site
Périgueux, 24004
Research Site
Perpignan, 66000
Research Site
Reims, 51092
Research Site
Saint-Grégoire, 35768
Research Site
Strasbourg, 67000
Research Site
Toulouse, 31076
Spain10 sites
Research Site
Bilbao, Basque Country, 48013
Research Site
Burgos, Castille and León, 09006
Research Site
Castellon, Valencia, 12002
Research Site
Granollers, Catalonia, 08402
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Ourense, Galicia, 32005
Research Site
Oviedo, Principality of Asturias, 33006
Research Site
Palma de Mallorca, Balearic Islands, 07198
Research Site
Pamplona, Navarre, 31008
Italy7 sites
Research Site
Foggia, 71100
Research Site
Legnago VR, 37045
Research Site
Naples, 80131
Research Site
Ravenna, 48100
Research Site
Roma, 00189
Research Site
Torino, 10126
Research Site
Vimercate MB, 20871
Belgium6 sites
Research Site
Bonheiden, 2820
Research Site
Brasschaat, 2930
Research Site
Bruges, 8000
Research Site
Haine Saint Paul - La Louviere, 7100
Research Site
Liège, 4000
Research Site
Merksem, 2170
Czechia6 sites
Research Site
Brno, 656 53
Research Site
Chomutov, 430 12
Research Site
Jihlava, 586 01
Research Site
Pilsen, 304 60
Research Site
Prague, 140 59
Research Site
Ústí nad Labem, 401 13
Sweden5 sites
Research Site
Eskilstuna, 631 88
Research Site
Gothenburg, 416 85
Research Site
Karlskrona, 378 85
Research Site
Skövde, 541 85
Research Site
Västerås, 721 89
Denmark4 sites
Research Site
Copenhagen, 2100
Research Site
Esbjerg, 6700
Research Site
Herning, 7400
Research Site
Hillerød, 3400
Netherlands3 sites
Research Site
Amstelveen, 1186 AM
Research Site
Doetinchem, 7009 BL
Research Site
Eindhoven, 5623 EJ
About this study
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Other
- Keywords
- Metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
Also called Medical Records Review
No intervention other than routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Round 1 | 50 oncologists participate in Round 1. At least 3 medical records will be reviewed per oncologist Receives: Other: Other | |
| 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 Receives: Other: Other | |
| 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 Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (5)
The proportion of oncologists who agree to participate in the study
Measured: 3 years
The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix
Measured: 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
The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.
Measured: 3 years
The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method
The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start19 Sep 2012
- Primary completion2 Jun 2015
- Study completion2 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791361
- Sponsor's protocol ID
- 20101120
- Status last verified
- Sep 2022
- First submitted
- 5 Jun 2012
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29183279
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
- ClinicalTrials.gov ID
- NCT01791361
- Acronym / sponsor ID
- 20101120
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 2 Jun 2015 (actual)
- Study completion
- 2 Jun 2015 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Round 1 | – | Other: Other50 oncologists participate in Round 1. At least 3 medical records will be reviewed per oncologist |
| Round 2 | – | Other: Other50 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 | – | Other: Other50 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherAlso: Medical Records ReviewNo intervention other than routine medical care | Other | Round 1, Round 2, Round 3 |
Primary outcome
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
5 secondary outcomes
The proportion of oncologists who agree to participate in the study
Time frame: 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
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 proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 29183279Han 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
84 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Amgen at 84 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in Germany, France, Spain, Italy, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01791361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.