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

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ClinicalTrials.gov Identifier: NCT00525746
Recruitment Status : Active, not recruiting
First Posted : September 6, 2007
Last Update Posted : December 5, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Leukemia Myelodysplastic Syndrome Behavioral: Interview

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 Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome
Actual Study Start Date : March 2006
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Group/Cohort Intervention/treatment
Patients with a confirmed diagnosis of AML or MDS (cases).
Behavioral: Interview
Interview lasting about 50 minutes.
Patients treated for a primary malignancy (controls).
Behavioral: Interview
Interview lasting about 50 minutes.

Primary Outcome Measures :
  1. Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples With DNA
Saliva or blood sample collected for special tests that will look for biologic factors associated with treatment-related AML/MDS.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525746

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jian Gu, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525746     History of Changes
Other Study ID Numbers: 2004-0490
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Keywords provided by M.D. Anderson Cancer Center:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Molecular Epidemiology
Epidemiologic markers
Clinical markers
Constitutional genetic markers
Case-comparison study

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions