GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis (GDF 15)

• ClinicalTrials.gov Identifier: NCT01201135
• Recruitment Status: Unknown
• First Posted: September 14, 2010
• Last Update Posted: September 14, 2010
• Sponsor: Wolfson Medical Center
• Information provided by: Wolfson Medical Center

Tracking Information

• First Submitted Date: September 12, 2010
• First Posted Date: September 14, 2010
• Last Update Posted Date: September 14, 2010
• Study Start Date: September 2010
• Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 12, 2010): GDF 15 [ Time Frame: year ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: September 12, 2010): Hepcidine [ Time Frame: year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis
• Official Title: The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis
• Brief Summary: Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis

Detailed Description

The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators.

In iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

The study will contain 40 patients with Sickle cell disease and 40 patients with hereditary spherocytosis.

After ICF (Informed Consent Form) has been signed by the patients the following laboratory tests will be taken once during the study:

1. GDF 15( 3ml of serum) (at the laboratory of hematology at Wolfson Medical Center/Israel)
2. Hepcidine (3ml of serum) (at the laboratory of Prof. T. Ganz, USA). The blood samples should be taken at least one week apart from blood transfusion.

In case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.

Condition

• Patients With Thalassemia Intermedia,
• Congenital Dyserythropoietic Anemia Type I

• Intervention: Not Provided

Study Groups/Cohorts

• Sickle cell disease
• hereditary spherocytosis.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 12, 2010): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2011
• Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• non

Exclusion Criteria:

• non

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01201135
• Other Study ID Numbers: GDF-15CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr' Ghoti Hossam, hematology department on Wolfsson Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Wolfson Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: GHOTI HOSSAM, doctor; HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER

• PRS Account: Wolfson Medical Center
• Verification Date: September 2010