Overview

This trial is active, not recruiting.

Condition leukemia
Treatment interview
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date September 2003
End date September 2017
Trial size 1200 participants
Trial identifier NCT00502983, ID03-0250

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. Researchers will 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, researchers 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
AML Patients & Healthy Controls
interview
Interview lasting approximately 50 minutes.

Primary Outcomes

Measure
Identify biologic and lifestyle factors that may increase a person's risk of developing acute myelogenous leukemia.
time frame: 8 Years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. A histologically confirmed diagnosis of AML (patients only) 2. Aged 18 or older 3. Resident of Texas 4. Willing and able to provide written informed consent and authorization 5. Willing to donate 10mL of blood and complete a personal interview Exclusion Criteria: 1. Under 18 years of age 2. History of invasive cancer, excluding non-melanoma skin cancer (controls only)

Additional Information

Official title Molecular Epidemiology of Acute Myelogenous Leukemia
Principal investigator Sara Strom, PhD
Description INFORMED CONSENTS FOR AML PATIENTS: For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. You 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 your convenience. You may be contacted at home by phone so that researchers can collect information about any changes in your 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, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. You 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 your convenience. THIS IS AN INVESTIGATIONAL STUDY. Up to 1,200 participants will take part in this study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.