An observational study in Metastatic Colorectal Cancer, sponsored by Amgen. Completed at 84 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Amgen · Observational
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 439 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Physician Exclusion Criteria:
Patient Inclusion Criteria
50 oncologists participate in Round 1. At least 3 medical records will be reviewed per oncologist
Other: Other
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
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
Also known as: Medical Records Review
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
Time frame: 3 years
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
The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.
Time frame: 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.
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
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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