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
  Purpose

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


Condition
Acute Myeloid Leukemia

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 75
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Umbilical cord blood

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Female hospital patients

Criteria

Inclusion Criteria:

  • Consenting women who have had full-term birth

Exclusion Criteria:

  • Systemic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329471

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Ofer Fainaru, MD, PhD       ofer.fainaru@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Weizmann Institute of Science
  More Information

No publications provided

Responsible Party: Dr. Ofer Fainaru, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01329471     History of Changes
Other Study ID Numbers: HYMC-16-2011
Study First Received: March 10, 2011
Last Updated: April 5, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014