NCT01511575

Brief Summary

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer. PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

January 13, 2012

Last Update Submit

May 13, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia in remissionchildhood acute myeloid leukemia/other myeloid malignancieschildhood acute megakaryocytic leukemia (M7)

Outcome Measures

Primary Outcomes (1)

  • Gene expression levels between DS AMKL and non-DS AMKL patients

Interventions

RNA analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder.

DISEASE CHARACTERISTICS: * Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder * Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1 PATIENT CHARACTERISTICS: * Previously consented to biologic studies 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

MeSH Terms

Conditions

Leukemia

Interventions

Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Jeffrey Taub, MD

    Children's Hospital of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 18, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05