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

NCT ID: NCT00525746

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2025-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Leukemia Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients with a confirmed diagnosis of AML or MDS (cases).

Interview

Intervention Type BEHAVIORAL

Interview lasting about 50 minutes.

Controls

Patients treated for a primary malignancy (controls).

Interview

Intervention Type BEHAVIORAL

Interview lasting about 50 minutes.

Interventions

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Interview

Interview lasting about 50 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Gu, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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2004-0490

Identifier Type: -

Identifier Source: org_study_id

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