Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502983
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2007-07-16
Brief Title:
Molecular Epidemiology of Acute Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Molecular Epidemiology of Acute Myelogenous Leukemia
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Little is known about the epidemiologic risk factors associated with the development of acute myelogenous leukemia AML and less is known about the role that genetic susceptibility plays in the development of AML We propose to conduct a population-based study to investigate genetic susceptibility in adult AML patients both de novo and treatment-related in a well-defined geographical area Using a case-control design we will prospectively enroll 400 patients from Texas and 800 healthy controls Controls will be recruited using random digit dialing and will be matched to the cases by age gender and ethnicity Epidemiological and demographic information will be obtained through personal interviews and will be integrated with clinical information cytogenetic data and genotypic markers Blood specimens will be collected on all participants who will be genotyped for markers associated with activation and detoxification of chemical carcinogens including chemotherapy drugs Polymorphisms in genes such as cytochrome p450 CYP2E1 glutathione S-transferases GSTT1 GSTM1 GSTP1 epoxide hydrolase HYL1 NADPH-quinone oxidoreductase NQO1 and myeloperoxidase MPO will be analyzed
This study will provide insight into the role that these susceptibility markers along with clinical epidemiological and cytogenetic factors play in the identification of people at risk of developing AML Understanding how genetic predisposition and exogenous exposures interact to determine AML susceptibility will allow the development of prevention strategies in the future
This study will provide insight into the role that these susceptibility markers along with clinical epidemiological and cytogenetic factors play in the identification of people at risk of developing AML Understanding how genetic predisposition and exogenous exposures interact to determine AML susceptibility will allow the development of prevention strategies in the future
Detailed Description:
INFORMED CONSENTS FOR AML PATIENTS
For this study participant will be asked to complete a personal interview During the interview participant will be asked questions about participants demographics age sex etc any chemicals participant may have been exposed to participants medical history family history of cancer participants diet and participants smoking and alcohol use histories It should take around 50 minutes to complete the interview
Participant will also have around 1 tablespoon of blood drawn for special tests These tests will look for any biologic factors associated with AML
The interview and the blood draw may be done during a regularly scheduled visit to M D Anderson or may be scheduled at the time and place of participants convenience
Participant may be contacted at home by phone so that researchers can collect information about any changes in participants health status
This is an investigational study Up to 1200 participants will take part in this study
INFORMED CONSENT FOR CONTROL SUBJECTS
For this study participant will be asked to complete a personal interview During the interview participant will be asked questions about participants demographics age sex etc any chemicals participant may have been exposed to participants medical history family history of cancer participants diet and participants smoking and alcohol use histories It should take around 50 minutes to complete the interview
Participant will also have around 1 tablespoon of blood drawn for special tests These tests will look for any biologic factors associated with AML The interview and blood draw will be scheduled at the time and place of participants convenience
This is an investigational study Up to 1200 participants will take part in this study
For this study participant will be asked to complete a personal interview During the interview participant will be asked questions about participants demographics age sex etc any chemicals participant may have been exposed to participants medical history family history of cancer participants diet and participants smoking and alcohol use histories It should take around 50 minutes to complete the interview
Participant will also have around 1 tablespoon of blood drawn for special tests These tests will look for any biologic factors associated with AML
The interview and the blood draw may be done during a regularly scheduled visit to M D Anderson or may be scheduled at the time and place of participants convenience
Participant may be contacted at home by phone so that researchers can collect information about any changes in participants health status
This is an investigational study Up to 1200 participants will take part in this study
INFORMED CONSENT FOR CONTROL SUBJECTS
For this study participant will be asked to complete a personal interview During the interview participant will be asked questions about participants demographics age sex etc any chemicals participant may have been exposed to participants medical history family history of cancer participants diet and participants smoking and alcohol use histories It should take around 50 minutes to complete the interview
Participant will also have around 1 tablespoon of blood drawn for special tests These tests will look for any biologic factors associated with AML The interview and blood draw will be scheduled at the time and place of participants convenience
This is an investigational study Up to 1200 participants will take part in this study
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