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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00525746
First received: September 4, 2007
Last updated: May 5, 2014
Last verified: May 2014
  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:

  1. 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.
  2. 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.
  3. 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)
  4. 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2016 (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
Study Population

Participants, 18 years or older, with a confirmed diagnosis of AML or MDS (cases), or treated for a primary malignancy (controls).

Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525746

Contacts
Contact: Sara Strom, PhD 713-563-1631

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sara Strom, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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, NCI-2010-00752
Study First Received: September 4, 2007
Last Updated: May 5, 2014
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 August 21, 2014