Functional Role of RUNX1 Mutations in the Etiology of Acute Myeloid Leukemia (AML)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Hillel Yaffe Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Weizmann Institute of Science

Information provided by:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01329471

First received: March 10, 2011

Last updated: April 5, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 10, 2011
Last Updated Date	April 5, 2011
Start Date ^ICMJE	April 2011
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 5, 2011)	Performance of expression arrays on transfected CD34+ cells [ Time Frame: One year ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01329471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Functional Role of RUNX1 Mutations in the Etiology of Acute Myeloid Leukemia (AML)
Official Title ^ICMJE	Not Provided
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
Detailed Description	The RUNX1 gene, located at chromosomal band 21q22, is a transcription factor, crucial for hematopoiesis and the generation of hematopoietic stem cells in the embryo. RUNX1 is the most frequent target for chromosomal translocation in leukemia. In addition, point mutations in the RUNX1 gene have been found to constitute an important mode of genetic alteration in development of leukemia. Recent publications stressing the clinical need for implementing RUNX1 point mutations as both a diagnostic and unfavorable prognostic marker of AML, have aroused particular interest in the functional role of RUNX1 in this disease. In order to pinpoint specific RUNX1 target genes involved in pre-leukemic transformation or exacerbation of existing leukemia, the investigators plan to compare expression profiles from human hematopoietic progenitors overexpressing a mutated form of RUNX1with controls (RUNX1 wild-type and knocked-down). In this study the investigators intend to collect blood, after receiving informed consent, from umbilical cords of neonates born vaginally, in order to isolate CD34+ hematopoietic progenitors. Human umbilical cord blood contains relatively high numbers of CD34+ cells, which may be frozen directly after collection and used as a source of progenitor cells for further culture or direct analysis.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Female hospital patients
Condition ^ICMJE	Acute Myeloid Leukemia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Umbilical cord blood
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	75
Estimated Completion Date	April 2013
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Consenting women who have had full-term birth Exclusion Criteria: Systemic disease
Gender	Female
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01329471
Other Study ID Numbers ^ICMJE	HYMC-16-2011
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Ofer Fainaru, Hillel Yaffe Medical Center
Study Sponsor ^ICMJE	Hillel Yaffe Medical Center
Collaborators ^ICMJE	Weizmann Institute of Science
Investigators ^ICMJE	Not Provided
Information Provided By	Hillel Yaffe Medical Center
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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