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NCT01229124 Clinical Trial

RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
SCOR in Targeted Therapies for Infant Leukemias Project 4: MicroRNA Sequencing of Infant AML

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01229124
Other study ID # AAML11B1
Secondary ID COG-AAML11B1NCI-
Status Active, not recruiting
Phase N/A
First received October 26, 2010
Last updated May 11, 2015
Start date October 2010

Study information
Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with acute myeloid leukemia.

Description:

OBJECTIVES:

- Sequence the microRNAs present in 20 infant AML samples as a pilot study.

- Compare microRNAs present in infant AML samples to infant ALL samples that are being concurrently sequenced in a separate study to identify lineage- and translocation-specific microRNAs.

OUTLINE: This is a multicenter study.

Previously collected cryopreserved cells from diagnosis are sequenced using reverse transcriptase-PCR.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia

- Available cryopreserved cells from diagnosis

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA analysis

• nucleic acid sequencing

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Sequence of the microRNAs present in 20 infant acute myeloid leukemia (AML) samples No
Primary Comparison of microRNAs present in infant AML samples to infant acute lymphoblastic leukemia samples to identify lineage- and translocation-specific microRNAs No
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