Molecular Epidemiology of Therapy-related Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS)

Active, not recruiting

• Conditions: Myelodysplastic Syndrome; Leukemia
• Interventions: Behavioral: Interview

• Registration Number: NCT00525746
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2006-03-31
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-05
• Study First Posted: 2007-09-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 191

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Interview	Patients treated for a primary malignancy (controls).
Cases	Interview	Patients with a confirmed diagnosis of AML or MDS (cases).

Primary Outcome Measures

Name	Time	Method
Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development	3 Years

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States