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

NCT00525746 | Unknown

• 1 other identifier: 2004-0490
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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).

Conditions

Leukemia; Myelodysplastic Syndrome

Keywords

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Leukemia; MDS; AML; Malignancy; Molecular Epidemiology; Epidemiologic markers; Clinical markers; Constitutional genetic markers; Case-comparison study

Outcome Measures

Primary Outcomes (1)

• Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development

  3 Years

Study Arms (2)

Cases

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

Behavioral: Interview

Controls

Patients treated for a primary malignancy (controls).

Behavioral: Interview

Interventions

Interview BEHAVIORAL

Interview lasting about 50 minutes.

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Under 18 years of age
• History of second primary malignancy (controls only)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

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.

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jian Gu, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: March 31, 2006
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

US (1)