Biomarker Study of Chemotherapy Resistance and Outcomes in Samples From Older Patients With Acute Myeloid Leukemia

NCT01421875 | Completed

• 2 other identifiers: CDR0000709403ECOG-E3999T4
• Study Type: observational
• Target: 257
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying blood samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and outcomes in samples from older patients with acute myeloid leukemia.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); untreated adult acute myeloid leukemia; adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0)

Outcome Measures

Primary Outcomes (1)

• Genetic and epigenetic determinants of chemoresistance and adverse outcomes

  1 year

Interventions

DNA methylation analysis GENETIC

RNA analysis GENETIC

gene expression analysis GENETIC

microarray analysis GENETIC

nucleic acid sequencing GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 61 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from patients enrolled E3999 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Subset of patients diagnosed with acute myeloid leukemia (AML) enrolled on E3999 * AML resistant or sensitive to chemotherapy * Mononuclear cell samples available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

DNA Methylation; Gene Expression Profiling; Microarray Analysis; Base Sequence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Molecular Structure; Genetic Structures

Study Officials

• Ross Levine, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2011
• First Posted: August 23, 2011
• Study Start: August 17, 2011
• Primary Completion: October 17, 2011
• Study Completion: October 17, 2011
• Last Updated: May 17, 2017

Record last verified: 2017-05