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

January 10, 2020 updated by: M.D. Anderson Cancer Center

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jian Gu, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2006

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 6, 2007

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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