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Study Detail

Study ID 1028
Name CIP: Differential Response to Hydroxyurea and Incidence of Stroke in Sickle Cell Disease
Contact Email agibbs@bcm.edu
Acronym CIP
Period 2015
Design Case-Control
Study PI Richard Gibbs
Institution Baylor College of Medicine
URL https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000691.v2.p1
CTGovID NA
Funding Agency NHGRI
Grant Number U54 HG003273
Overview The Sickle cell CIP project is investigating complication of stroke and pharmacogenomics of hydroxyurea response in patients with sickle cell anemia. We will perform whole exome and whole genome sequencing of SCA patients in order to identify genome variants associated with incidences of stroke and HbF response to hydroxyurea.
Focus Areas 1. Incidence of Stroke
2. Fetal Hemoglobin (HbF) Response to Hydroxyurea
3. Whole Exome Sequencing
4. Whole Genome Sequencing
Outcomes 1. Hydroxyurea Response
2. Stroke Incidence
Data Location dbGaP
Biospecimen Available Blood; DNA; Plasma; Serum;
Data Consent dbGaP
Biospecimen Consent dbGaP
Contact Consent dbGaP
Genomic Data Yes
Age Range 3-22
No. Participants 651
Inclusion Criteria 1. Patients with sickle cell anemia.
2. History of hydroxyurea use with evidence of drug related myelosupression, such as an absolute neutrophil count (ANC) of less than 4000/UL.
3. Age between 3 years and 22 years inclusive.
4. Or patients with sickle cell anemia and a history of overt clinical stroke.
Exclusion Criteria Any subject who does not meet the inclusion criteria.
Study Documentation
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Data ElementVariables
Address
Age START_AGE
Ethnic Group
Gender SEX
Language
National Origin
Nuclear Family
Race
Data ElementVariables
Blood Differential Test
Blood Gases
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count BL F/F+S
MTD F/F+S
Comprehensive Metabolic Panel (CMP)
Enzyme
General
Hemoglobin Typing
Iron
Data ElementVariables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea HU mg/kg
Medication
Neurologic Medication History
Pain
SCD Medication
Sildenafil
Supplements
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