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


N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndrome

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Trial Information

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


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Sara Strom, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0490

NCT ID:

NCT00525746

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • MDS
  • AML
  • Malignancy
  • Molecular Epidemiology
  • Epidemiologic markers
  • Clinical markers
  • Constitutional genetic markers
  • Case-comparison study
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030