Clinical trial NCT00525746: Molecular Epidemiology of Therapy-related Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS)
Official title: Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Myelodysplastic Syndrome
Keywords: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Leukemia
MDS
AML
Malignancy
Molecular Epidemiology
Epidemiologic markers
Clinical markers
Constitutional genetic markers
Case-comparison study
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-06
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants, 18 years or older, with a confirmed diagnosis of AML or MDS (cases), or treated for a primary malignancy (controls).

Brief summary: The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome after treatment for a previous cancer (treatment-related AML/MDS).

Detailed description: For this study, you will be asked to take part in a personal or mail 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. Treatment information from your medical records at M. D. Anderson will also be collected.

You will be asked to provide a saliva sample or have around 1 tablespoon of blood drawn for special tests. These tests will look for biologic factors associated with treatment-related AML/MDS.

Your participation in this study will be over once the interview has been completed and blood or saliva have been collected.

This is an investigational study. Up to 600 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Willing and able to provide written informed consent and authorization
3. Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview
4. A histologically confirmed diagnosis of AML or MDS (cases only)
5. A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)
6. Enrolled in leukemia/MDS studies under protocol ID00-173 or ID03-0250 (cases only)
7. Treated for a primary malignancy at MDACC (controls only)
8. Matched to cases (2:1) by cases' prior malignancy(site, treatment (chemo and/or radiation), year of diagnosis (+/- 3 years)), age (+/- 5 years), sex, and ethnicity. (controls only)

Exclusion Criteria:

1. Under 18 years of age
2. History of second primary malignancy (controls only)

Primary outcomes:
measure: Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jian Gu, PhD
role: PRINCIPAL_INVESTIGATOR
References: