NCT01329471

Brief Summary

The purpose of this study is to elucidate the role of RUNX1 in Acute Myeloid Leukemia (AML), in particular, the transcriptional regulation of genes by mutated forms of this protein. This research will study the effect of mutations found in AML patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

March 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

March 10, 2011

Last Update Submit

April 5, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance of expression arrays on transfected CD34+ cells

    Performance of expression arrays on transfected CD34+ cells (derived from human cord blood), expecting differential gene expression between the wild type RUNX1-transfected cells and mutated RUNX1-transfected cells.

    One year

Study Arms (1)

Umbilical cord blood

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female hospital patients

You may qualify if:

  • Consenting women who have had full-term birth

You may not qualify if:

  • Systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 10, 2011

First Posted

April 6, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations