NCT01247584

Brief Summary

RATIONALE: Studying bone marrow samples 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 research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

5.5 years

First QC Date

November 23, 2010

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancieschildhood acute erythroleukemia (M6)childhood acute megakaryocytic leukemia (M7)childhood acute monoblastic leukemia (M5a)childhood acute monocytic leukemia (M5b)childhood acute myeloblastic leukemia without maturation (M1)childhood acute myelomonocytic leukemia (M4)childhood acute myeloblastic leukemia with maturation (M2)

Outcome Measures

Primary Outcomes (4)

  • Frequency of mutations

  • Relapse-free survival

  • Overall survival

  • Difference in telomere length

Interventions

DNA analysisGENETIC
mutation analysisGENETIC
polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of acute myeloid leukemia.

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Enrolled on CCG-2961 and meeting 1 of the following criteria: * More than 35 days to recover to an ANC \> 500/mm³ after any course of chemotherapy * Consistently recovered \< 35 days to an ANC \> 500/mm³ after all courses of chemotherapy * Available cryopreserved cell from diagnostic and end-of-therapy samples PATIENT CHARACTERISTICS: * Not specified 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

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow

MeSH Terms

Conditions

Leukemia

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Maria M. Gramatges, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05