Neutrophil Extracellular Traps and Sickle Cell Disease
Sponsors
Source
Tel-Aviv Sourasky Medical Center
Oversight Info
Has Dmc
No
Brief Summary
NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea
treatment.The study hypothesis is that NETs formation by neutrophils has a role in the
induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte
count in children with sickle cell anemia is a bad prognostic sign due to NETs formation
supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might
prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil
count and inhibiting NETs formation.
Overall Status
Not yet recruiting
Start Date
2014-02-01
Completion Date
2019-12-01
Primary Completion Date
2019-12-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
measurements of neutrophil function |
at first admition (day 1) |
Secondary Outcome
Measure |
Time Frame |
|
measurements of neutrophil function |
at sickle cell crisis while hospitalized |
Enrollment
15
Condition
Eligibility
Study Pop
Infants and children who suffer from sickle cell disease and/or Infants and children with
sickle cell disease treated with hydroxyurea at the pediatric hemato-oncology department
Sampling Method
Probability Sample
Criteria
Inclusion Criteria:
- children who suffer from sickle cell disease and/or children with sickle cell disease
treated with hydroxyurea
Exclusion Criteria:
Gender
All
Minimum Age
1 Month
Maximum Age
18 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ronit Elhasid, MD |
Principal Investigator |
Tel-Aviv Sourasky Medical Center |
Overall Contact
Verification Date
2012-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Biospec Retention
Samples Without DNA
Biospec Descr
10CC of peripheral venous blood will be collected from each patient at several time points:
at diagnosis ,during pain crisis , at Hydroxyurea treatment.
Other Outcome
Measure
measurements of neutrophil function
Time Frame
before and during treatment with hydroxyurea
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
October 15, 2013
Study First Submitted Qc
December 3, 2013
Study First Posted
December 9, 2013
Last Update Submitted
December 3, 2013
Last Update Submitted Qc
December 3, 2013
Last Update Posted
December 9, 2013
ClinicalTrials.gov processed this data on August 22, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.