Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 6:43 PM
Study NCT ID:
NCT01652833
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Physician Survey of EGFR Inhibitor Prescribing Patterns
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
Survey of Oncologists in Europe to Evaluate Their Knowledge of KRAS Testing
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To ensure the appropriate administration of Vectibix for the treatment of mCRC with wild-type KRAS in real-world practice, it is important to understand the awareness of practicing oncologists regarding the correct indication and appropriate administration of Vectibix. It is also critical to monitor changes in oncologists' awareness and practice between the different rounds of the study.
Detailed Description:
The survey will be conducted for 3 rounds in months 0, 12, and 24 after the first interview.
Before the beginning of each round, a sampling list will be created by Amgen.
In each round of the survey, potential participating oncologists will be sampled from each country's sampling list through random sampling and reached through telephone, letter or email. During the initial contact, the oncologists will be assessed for their eligibility to participate in the study by using a standardized screening questionnaire.
The initial contact and screening of potential participating oncologists will continue until a total of 150 eligible oncologists agree to participate in each round. The number of oncologists sampled in each country will be proportional to the use of Vectibix in each country and the number of oncology physicians estimated to prescribe Vectibix. Each eligible oncologist can only participate in 1 of the 3 rounds of survey.
Study staff will then conduct the survey with each of the identified eligible oncologists over the telephone, using a standardized questionnaire. Information about their awareness of the correct indication and appropriate administration of Vectibix and their experience in the administration of Vectibix treatment in the previous 6 months will be collected. We will make every attempt to collect the correct information from participating oncologists. This may require at least two phone calls to allow an oncologist to review their notes in order to report the correct data.
Before the beginning of each round, a sampling list will be created by Amgen.
In each round of the survey, potential participating oncologists will be sampled from each country's sampling list through random sampling and reached through telephone, letter or email. During the initial contact, the oncologists will be assessed for their eligibility to participate in the study by using a standardized screening questionnaire.
The initial contact and screening of potential participating oncologists will continue until a total of 150 eligible oncologists agree to participate in each round. The number of oncologists sampled in each country will be proportional to the use of Vectibix in each country and the number of oncology physicians estimated to prescribe Vectibix. Each eligible oncologist can only participate in 1 of the 3 rounds of survey.
Study staff will then conduct the survey with each of the identified eligible oncologists over the telephone, using a standardized questionnaire. Information about their awareness of the correct indication and appropriate administration of Vectibix and their experience in the administration of Vectibix treatment in the previous 6 months will be collected. We will make every attempt to collect the correct information from participating oncologists. This may require at least two phone calls to allow an oncologist to review their notes in order to report the correct data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: