Clinical trial · Observational
Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia
Observational - Rapid Identification of Leukemia Stem Cells Associated With AML1-ETO and Inv(16) Through Characterization of Oncogene-Induced Changes in Cell-Surface Antigen Profiles on Hematopoietic Stem Cells
NCT01642121CI-TRIAL-00022297completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This laboratory study is looking into biomarkers in samples from younger patients with acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myeloid Leukemia without Maturation | ALIAS | 0.90 |
| Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies | — | UNRESOLVED | — |
| Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myelomonocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell PCR analysis, flow cytometry, and reverse-transcriptase PCR. Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by FACS.
- interventionNames
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Expression of the CD55 marker on CD34+CD38- cells
- timeFrame
- Up to 6 months
- measure
- Presence of the AML1-ETO translocation
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (AML) patients possessing defined cytogenetic mutations; AML1-ETO or inv(16) * Samples of cytogenetically normal AML cases obtained from the University of Alabama at Birmingham (UAB) as controls
References
Publications (0)
Data not yet available
No reference posted for this study.