Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05541224
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2022-09-12
Brief Title:
A Retrospective Epidemiologic Registry to Gain Insight Into the Characteristics and Prognosis of AML Patients According to the Routinely Used Genetic and Biologic Markers
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A Retrospective Epidemiologic Registry to Gain Insight Into the Characteristics and Prognosis of AML Patients According to the Routinely Used Genetic and Biologic Markers
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:
This is a retrospective translational epidemiologic multicenter non-interventional study No EPA study to provide insights into disease epidemiology disease biology treatment regimens and clinical outcomes of patients with acute myeloblastic leukemia AML in routine clinical practice according to their molecular markers
The primary objective of the study is to describe the use of the main molecular markers FLT3 and NPM1 in the real-life according of the type of AML treating institution patients characteristics and disease status
The primary objective of the study is to describe the use of the main molecular markers FLT3 and NPM1 in the real-life according of the type of AML treating institution patients characteristics and disease status
Detailed Description:
This is a retrospective translational epidemiologic multicenter non-interventional study No EPA study to provide insights into disease epidemiology disease biology treatment regimens and clinical outcomes of patients with AML in routine clinical practice according to their molecular markers
Once it has been confirmed that all selection criteria for the study have been met and informed consent has been obtained the subject will be considered enrolled in the study and the investigator can proceed to collect data from their medical record by completing a case report CRF
The study contemplates the retrospective collection of data from disease diagnosis to the start of the study Only data obtained before the start of the study will be collected in order to ensure they are retrospective in nature
The study will be conducted following the requirements contained in the Declaration of Helsinki Fortaleza Brazil 2013 and in accordance with the current Spanish legislation with regard to conducting observational studies Ministerial Order SAS34702009
The primary objective of the study is to describe the use of the main molecular markers FLT3 and NPM1 in the real-life according of the type of AML treating institution patients characteristics and disease status
This project will be conducted in the Spanish PETHEMA cooperative group constituted by 60 institutions and seven main central laboratories with extensive technological capacity All patients will be included in the ongoing PETHEMA epidemiologic registry of AML with the purpose to collect a large number additional and non-pre-existent clinical data including first-line and salvage treatment schedules and outcomes of each patient
For this study the PETHEMA AML registry will be enlarged seeking for new cases not previously reported The data base information will be updated emphasizing for the capture of new data on molecular screening tests performed on a routine basis FLT3 NPM1 and others For these purpose information will be systematically requested from the main PETHEMA laboratories Therapies and clinical outcome data will be retrospectively collected This is a one-step study without intervention in which all analyses will be performed at the end of the database completion
Once it has been confirmed that all selection criteria for the study have been met and informed consent has been obtained the subject will be considered enrolled in the study and the investigator can proceed to collect data from their medical record by completing a case report CRF
The study contemplates the retrospective collection of data from disease diagnosis to the start of the study Only data obtained before the start of the study will be collected in order to ensure they are retrospective in nature
The study will be conducted following the requirements contained in the Declaration of Helsinki Fortaleza Brazil 2013 and in accordance with the current Spanish legislation with regard to conducting observational studies Ministerial Order SAS34702009
The primary objective of the study is to describe the use of the main molecular markers FLT3 and NPM1 in the real-life according of the type of AML treating institution patients characteristics and disease status
This project will be conducted in the Spanish PETHEMA cooperative group constituted by 60 institutions and seven main central laboratories with extensive technological capacity All patients will be included in the ongoing PETHEMA epidemiologic registry of AML with the purpose to collect a large number additional and non-pre-existent clinical data including first-line and salvage treatment schedules and outcomes of each patient
For this study the PETHEMA AML registry will be enlarged seeking for new cases not previously reported The data base information will be updated emphasizing for the capture of new data on molecular screening tests performed on a routine basis FLT3 NPM1 and others For these purpose information will be systematically requested from the main PETHEMA laboratories Therapies and clinical outcome data will be retrospectively collected This is a one-step study without intervention in which all analyses will be performed at the end of the database completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None