Metadata Catalog

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 Select All	CIP-SCD_phs000691
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Clinical status (0)

Behavior (0)

Blood (0)

Cancer (0)

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Lymphatic (0)

Medical Event (0)

Medical History (0)

Mental Health (0)

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Neurodevelopmental (0)

Neurologic (0)

Nutritional and Metabolic (0)

Ocular (0)

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Pain (0)

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Skin (0)

Sleep (0)

Surgery History (0)

COVID-19 (0)

Diagnosis (0)

Impact (0)

Treatment (0)

Vaccination (0)

Demographics (2)

Data Element	Variables
Address
Age	START_AGE
Ethnic Group
Gender	SEX
Language
National Origin
Nuclear Family
Race

Social Determinants of Health (SDoH) (0)

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Healthcare utilization (0)

Health Services (0)

Hospitalization (0)

SCD Management (0)

Imaging (0)

Angiogram (0)

Catheterization (0)

CT Scan (0)

Echocardiogram (0)

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

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Tests (2)

Biopsy (0)

Blood (2)

Data Element	Variables
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

Cardiovascular (0)

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Microbiology Culture (0)

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Other (0)

Physical Exam (0)

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Therapeutics (1)

Medication (1)

Data Element	Variables
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

Surgery (0)

Transfusion (0)

Transplantation (0)

Treatment (0)

Study Publications

Whole exome sequencing identifies novel genes for fetal hemoglobin response to hydroxyurea in children with sickle cell anemia

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