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Genes Influencing Iron Overload State


N/A
N/A
N/A
Open (Enrolling)
Both
Sickle Cell Disease, Thalassemia, Marrow Aplasia

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Trial Information

Genes Influencing Iron Overload State


This study will focus on the following primary objective:

- To investigate the association of GSTM1 gene deletion and liver iron concentration in
patients with sickle cell disease and transfusional iron-overload.

The Secondary Objectives of the study are:

- To explore the role of other iron metabolism-associated candidate genes on liver iron
concentration of sickle cell patients with transfusional iron-overload.

- To explore the role of GSTM1 genotypes and other iron metabolism-associated candidate
genes on maintenance and decline of liver iron concentration of patients with sickle
cell disease and transfusional iron-overload.

- To explore the role of GSTM1 genotypes and other iron metabolism-associated candidate
genes on increase, maintenance, and decline of iron concentration in the heart,
pancreas, kidneys, and spleen of patients with sickle cell disease and transfusional
iron overload.

- To explore the role of GSTM1 gene deletion and other iron metabolism-associated
candidate genes on increase, maintenance, and decline of iron concentration in the
liver, heart, pancreas, kidneys, and spleen of non-sickle cell patients with
transfusional iron-overload.

- To explore the relationship between Non-Transferrin Bound Iron (NTBI), hepcidin, organ
function, and iron increase, maintenance, and decline in the liver, heart, pancreas,
kidneys, and spleen of patients with transfusional iron overload.


Inclusion Criteria:



- History of ≥ 12 lifetime erythrocyte transfusions who have not yet initiated
treatment to unload iron (iron chelation or therapeutic phlebotomy), or

- History of ≥ 12 lifetime erythrocyte transfusions who have initiated treatment to
unload iron, but had liver iron content measurement (by R2*MRI) within 3 months prior
to initiation of iron unloading treatment

Exclusion Criteria

- Known contraindication to performance of MRI (e.g.: presence of MRI-incompatible
ferromagnetic material in the body)

- Prior participation on the MRIRON protocol

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

This study will measure genetic modifiers influencing the iron overload status of patients receiving transfusions.

Outcome Description:

This study will measure the association between GSTM1 gene deletion and other candidate genes and the accumulation and clearance of body iron.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Jane Hankins, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

GENIOS

NCT ID:

NCT01158794

Start Date:

August 2010

Completion Date:

July 2016

Related Keywords:

  • Sickle Cell Disease
  • Thalassemia
  • Marrow Aplasia
  • Iron overload
  • Blood Transfusion
  • Anemia, Sickle Cell
  • Thalassemia
  • Iron Overload

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794