NCT01108497

Brief Summary

We will study gene and protein expression in leukemia cells of children diagnosed with acute leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis in order to: (a) develop better means of diagnosis and (b) more accurately choose the best therapy for each patient.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2001

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

14.2 years

First QC Date

April 20, 2010

Last Update Submit

June 22, 2016

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • Gene Expression

    days 0, 8, 22 or 29

Interventions

Bone Marrow AspirationPROCEDURE

Eligibility Criteria

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

All children who present at Packard hospital with a new diagnosis or relapse of acute leukemia will be eligible.

You may qualify if:

  • \. Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

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 James Lacayo

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 22, 2010

Study Start

July 1, 2001

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 24, 2016

Record last verified: 2016-06

Locations

US(1)