Molecular Epidemiology of Acute Myelogenous Leukemia

NCT00502983 | Unknown

• 1 other identifier: ID03-0250
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Acute Myelogenous Leukemia; Epidemiology; Leukemia; Healthy Control; Lifestyle Factors; Genetic Susceptibility; Interview; AML

Outcome Measures

Primary Outcomes (1)

• Identify biologic and lifestyle factors that may increase a person's risk of developing acute myelogenous leukemia.

  8 Years

Study Arms (1)

Interview

AML Patients \& Healthy Controls

Behavioral: Interview

Interventions

Interview BEHAVIORAL

Interview lasting approximately 50 minutes.

Interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• A histologically confirmed diagnosis of AML (patients only)
• Aged 18 or older
• Resident of Texas
• Willing and able to provide written informed consent and authorization
• Willing to donate 10mL of blood and complete a personal interview

You may not qualify if:

• Under 18 years of age
• History of invasive cancer, excluding non-melanoma skin cancer (controls only)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collection to look for any biologic factors associated with AML.

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Genetic Predisposition to Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jian Gu, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: June 23, 2003
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)