NCT00899652

Brief Summary

RATIONALE: Studying samples of bone marrow and blood 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 laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1997

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

Study Start

First participant enrolled

January 1, 1997

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

8.7 years

First QC Date

May 9, 2009

Last Update Submit

April 24, 2017

Conditions

Leukemia

Keywords

childhood acute myelomonocytic leukemia (M4)childhood acute monocytic leukemia (M5b)childhood acute monoblastic leukemia (M5a)secondary acute myeloid leukemiauntreated childhood acute lymphoblastic leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesrecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemia

Outcome Measures

Primary Outcomes (2)

  • Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML)

  • Comparison of secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites

Study Arms (1)

All Patients

Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.

Genetic: Southern blottingGenetic: chromosomal translocation analysisGenetic: cytogenetic analysisGenetic: gene rearrangement analysisGenetic: mutation analysis

Interventions

Southern blottingGENETIC
All Patients
chromosomal translocation analysisGENETIC
All Patients
cytogenetic analysisGENETIC
All Patients
gene rearrangement analysisGENETIC
All Patients
mutation analysisGENETIC
All Patients

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of leukemia meeting 1 of the following criteria: * Acute lymphoblastic leukemia OR acute myeloid leukemia (AML) (\< 1 year of age at diagnosis) * M4 OR M5 AML (\< 5 years of age at diagnosis) * Secondary leukemia (\< 21 years of age at diagnosis) * Bone marrow sample, peripheral blood (WBC \> 10,000/mm³ and 20% peripheral blasts), or pheresis bag available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

marrow, blood, pheresis bag

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Blotting, SouthernCytogenetic AnalysisGene Rearrangement

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesMolecular Probe TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic TechniquesGenetic Phenomena

Study Officials

  • Beverly J. Lange, MD

    Children's Hospital of Philadelphia

    STUDY CHAIR

  • Carolyn A. Felix, MD

    Children's Hospital of Philadelphia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

January 1, 1997

Primary Completion

September 1, 2005

Study Completion

September 1, 2006

Last Updated

April 26, 2017

Record last verified: 2017-04