Molecular Epidemiology of Therapy-related Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS)
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Purpose
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).
Primary Objectives:
- To identify a well-characterized population of 300 t-AML/MDS patients (cases) among patients enrolled in ongoing AML and MDS studies (Protocols ID00-173 and ID03-0250) by the end of 2007.
- To identify and recruit a comparison group consisting of 600 patients treated at MDACC and have not developed second primary malignancies (controls) by the end of 2007. Controls will be matched to cases (2:1) on the cases' first malignancy (site, treatment (chemotherapy and/or radiation therapy), year of diagnosis (+/-3 years)), sex, age (+/- 5 years) and ethnicity.
To evaluate constitutional genetic markers as risk factors for t-AML/MDS development. Researchers propose to evaluate polymorphisms associated with:
- Metabolism of therapeutic agents (CYP2E1, CYP3A4, GSTT1, GSTM1, NQO1, MPO, multiple drug resistance)
- DNA repair (XRCC1, XPD, and XRCC3)
- To explore the interplay between clinical, epidemiologic, and molecular factors to determine their significance in predicting risk of t-AML/MDS.
| Condition | Intervention |
|---|---|
|
Leukemia Myelodysplastic Syndrome |
Behavioral: Interview |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome |
- Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cases
Patients with a confirmed diagnosis of AML or MDS (cases).
|
Behavioral: Interview
Interview lasting about 50 minutes.
|
|
Controls
Patients treated for a primary malignancy (controls).
|
Behavioral: Interview
Interview lasting about 50 minutes.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants, 18 years or older, with a confirmed diagnosis of AML or MDS (cases), or treated for a primary malignancy (controls).
Inclusion Criteria:
- Age 18 years or older
- Willing and able to provide written informed consent and authorization
- Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview
- A histologically confirmed diagnosis of AML or MDS (cases only)
- A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)
- Enrolled in leukemia/MDS studies under protocol ID00-173 or ID03-0250 (cases only)
- Treated for a primary malignancy at MDACC (controls only)
- 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:
- Under 18 years of age
- History of second primary malignancy (controls only)
Contacts and Locations| Contact: Sara Strom, PhD | 713-563-1631 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Sara Strom, PhD | |
| Principal Investigator: | Sara Strom, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00525746 History of Changes |
| Other Study ID Numbers: | 2004-0490 |
| Study First Received: | September 4, 2007 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Acute Myeloid Leukemia Myelodysplastic Syndrome Leukemia MDS AML Malignancy |
Molecular Epidemiology Epidemiologic markers Clinical markers Constitutional genetic markers Case-comparison study |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on June 18, 2013