Back to Search Results
Study Complete
Sponsor ID
20101120

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

Sponsor ID
20101120
Clinicaltrials.gov ID
NCT01791361
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
N/A
Product
panitumumab
Type
Observational
Masking
N/A
Enrollment
439
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 3 years

Secondary Outcome Measures

The proportion of oncologists who agree to participate in the study

Timeframe: 3 years

The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix

Timeframe: 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

Timeframe: 3 years

The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method

Timeframe: 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

Timeframe: 3 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Avignon, France, 84000
Status
Completed
Location
Research Site
Bordeaux Cedex, France, 33030
Status
Completed
Location
Research Site
Grenoble Cedex 9, France, 38043
Status
Completed
Location
Research Site
Marseille Cedex 08, France, 13285
Status
Completed
Location
Research Site
Nancy, France, 54100
Status
Completed
Location
Research Site
Périgueux cedex, France, 24004
Status
Completed
Showing {first} - {last} of {total} Results
Study Info
Age
18+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Sep 2012 - Jun 2015
    Inclusion and Exclusion Criteria
    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