Molecular Epidemiology of Acute Myelogenous Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502983
First received: July 16, 2007
Last updated: September 27, 2013
Last verified: September 2013
  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. 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.


Condition Intervention
Leukemia
Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Acute Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Identify biologic and lifestyle factors that may increase a person's risk of developing acute myelogenous leukemia. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Interview
AML Patients & Healthy Controls
Behavioral: Interview
Interview lasting approximately 50 minutes.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

UT MDACC Patients with Acute Myelogenous Leukemia and healthy controls, all 18 years of age or older and Texas residents.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502983

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sara Strom, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502983     History of Changes
Other Study ID Numbers: ID03-0250
Study First Received: July 16, 2007
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
Epidemiology
Leukemia
Healthy Control
Lifestyle Factors
Genetic Susceptibility
Interview
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014