This trial is active, not recruiting.

Conditions leukemia, myelodysplastic syndrome
Treatment interview
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date March 2006
End date March 2018
Trial size 600 participants
Trial identifier NCT00525746, 2004-0490


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Patients with a confirmed diagnosis of AML or MDS (cases).
Interview lasting about 50 minutes.
Patients treated for a primary malignancy (controls).
Interview lasting about 50 minutes.

Primary Outcomes

Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development
time frame: 3 Years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome
Principal investigator Jian Gu, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.