S9031-S9126-S9333-S9500-A, Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia
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Purpose
RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at bone marrow and blood samples from patients with acute myeloid leukemia.
| Condition | Intervention |
|---|---|
|
Leukemia |
Genetic: DNA analysis Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | S9031-S9126-S9333-S9500-A, Examination of the Prognostic Significance of AML-Specific and Age-Associated Genes in AML Patients |
- Prognostic significance for complete response, overall survival, and relapse-free survival of total and relative expression levels (variant/wild type ratios) for each gene [ Time Frame: immediate ] [ Designated as safety issue: No ]
- Role of acute myeloid leukemia (AML)-specific and age-associated genes in the biology and prognosis of AML [ Time Frame: immediate ] [ Designated as safety issue: No ]
- Role of methylation and histone modification in IRF8 gene expression [ Time Frame: immediate ] [ Designated as safety issue: No ]
| Enrollment: | 251 |
| Study Start Date: | November 2008 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To determine whether the expression of previously identified acute myeloid leukemia (AML)-specific and age-associated genes have prognostic significance in adult patients with AML.
- To examine, preliminarily, if AML-specific and age-associated expression changes occur in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).
- To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG island/promoter region is correlated with IRF8 gene expression in AML.
OUTLINE: This is a multicenter study.
Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays and linked to clinical and outcome data from the main SWOG database. Samples from a subset of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with methylation or histone modification of the IRF8 CPG island/promoter region.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients enrolled on S9031, S9333, S0106 or S0112 that consented to use of specimens for future research
DISEASE CHARACTERISTICS:
Pretreatment RNA specimens* available from patients with acute myeloid leukemia (AML) registered for front-line therapy on the following clinical trials:
- SWOG-9031
- SWOG-9126
- SWOG-9333
- SWOG-9500
- Cryopreserved pretreatment cell specimens* available from a subset of patients (those who obtained a complete response [CR] and remained in CR without relapse for ≥ 2 years vs those with resistant disease [i.e., failed to achieve CR with evidence of persistent AML following induction therapy]) NOTE: All specimens currently available in the Southwest Oncology Group Myeloid Leukemia and MDS Repository at the University of New Mexico
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00899171 History of Changes |
| Other Study ID Numbers: | CDR0000614113, S9031-S9126-S9333-S9500-A, U10CA032102 |
| Study First Received: | May 9, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia adult acute erythroid leukemia (M6) |
adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) secondary acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013