Molecular Epidemiology of Acute Myelogenous Leukemia

Leukemia Clinical Trial

Official title: Molecular Epidemiology of Acute Myelogenous Leukemia

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 participant's demographics (age, sex, etc.), any chemicals participant may have been exposed to, participant's medical history, family history of cancer, participant's diet, and participant's 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 participant's convenience.

Participant may be contacted at home by phone so that researchers can collect information about any changes in participant's health status.

This is an investigational study. Up to 1,200 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 participant's demographics (age, sex, etc.), any chemicals participant may have been exposed to, participant's medical history, family history of cancer, participant's diet, and participant's 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 participant's convenience.

This is an investigational study. Up to 1,200 participants will take part in this study. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT00502983
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Start date: June 23, 2003
• Completion date: September 30, 2020