NCT01321385

Brief Summary

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This research trial is studying biomarkers in predicting response to treatment in bone marrow 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
97

participants targeted

Target at P50-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

March 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

5.2 years

First QC Date

March 22, 2011

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemiauntreated childhood acute myeloid leukemia and 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 with maturation (M2)childhood acute myeloblastic leukemia without maturation (M1)childhood acute myelomonocytic leukemia (M4)childhood acute minimally differentiated myeloid leukemia (M0)

Outcome Measures

Primary Outcomes (1)

  • Accuracy of induction response prediction

Secondary Outcomes (4)

  • Duration of complete response

  • Event-free survival and overall survival

  • Status (dead vs living)

  • Date of last follow up

Interventions

laboratory biomarker analysisOTHER
study of socioeconomic and demographic variablesOTHER

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 (AML) * Non-M3 AML * Cryopreserved bone marrow mononuclear cell specimens from patients enrolled on COG-AAML03P1 and COG-AAML0531 collected prior to cytarabine-based induction therapy * Patient samples from COG-AAML0531 must come from the control arm (i.e., no gemtuzumab ozogamicin induction therapy) PATIENT CHARACTERISTICS: * No Down syndrome 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

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Norman J. Lacayo, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05