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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00502983 |
Purpose
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.
| Condition | Intervention |
|
Leukemia |
Behavioral: Interview |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Molecular Epidemiology of Acute Myelogenous Leukemia |
Blood sample collection to look for any biologic factors associated with AML.
| Estimated Enrollment: | 1200 |
| Study Start Date: | September 2003 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|
1
Patients with Acute Myelogenous Leukemia and healthy controls.
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Behavioral: Interview
Interview lasting approximately 50 minutes.
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Informed Consent 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. There are no costs associated with participating in this 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. There are no costs associated with participating in this study. Up to 1,200 participants will take part in this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients with Acute Myelogenous Leukemia and healthy controls.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sara Strom, PhD | 713-792-3020 |
| United States, Texas | |||||
| U.T.M.D. Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Principal Investigator: Sara Strom, PhD | |||||
| M.D. Anderson Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Sara Strom, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Sara Strom, PhD/Associate Professor ) |
| Study ID Numbers: | ID03-0250 |
| First Received: | July 16, 2007 |
| Last Updated: | January 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00502983 |
| Health Authority: | United States: Institutional Review Board |
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