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

Leukemia Clinical Trial

Official title:

Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00525746
• Other study ID #: 2004-0490
• Status: Active, not recruiting
• Start date: March 31, 2006
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 191
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Behavioral:
• Interview
Interview lasting about 50 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development		3 Years

External Links

•   University of Texas MD Anderson Cancer Center Website