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Study Detail

Study ID 1007
Name Sickle Cell Clinical Research and Intervention Program
Contact Email jane.hankins@stjude.org
Acronym SCCRIP
Period 2014 -
Design Lifespan cohort study
Study PI Jane S. Hankins
Institution St. Jude Children's Research Hospital
URL https://www.stjude.org/research/clinical-trials/sccrip-hematological-disorder.html
CTGovID NA
Funding Agency St. Jude Children's Research Hospital
Grant Number 1U01HL133996-01
Overview The purpose of this research study is to collect data on sickle cell disease participants from birth to young adulthood. With these data, researchers will better understand problems caused by sickle cell disease both in children and in adults. They will also look at long term effects of current treatments, and use these data as a building block for future research.
Focus Areas 1. To determine the incidence, prevalence, and severity of SCD complications and adverse health conditions within the SCD cohort during five stages of development: the newborn period (birth to 6 months), the infant/pre-school stage (ages 6 months to 6 years), the early school stage (ages 6 to 12 years), the adolescent stage (ages 12 to 18 years), and the years of transition into young adulthood (ages 18 to 25 years).
2. To identify and evaluate risk factors for premature mortality and long-term morbidity in patients with SCD, including those related to disease-modifying therapies, end-organ damage, genetics, neurocognitive deficits, psychosocial factors, and behavioral causes.
3. To investigate the long-term effects of hydroxyurea and other therapies on preservation of organ function, growth and development, and frequency and severity of disease complications, and their long-term medical, neurocognitive, and psychosocial toxicities.
4. To determine the functional aspects of the Transition to Adult Care Program within a clinical research cohort by evaluating disease specific health literacy and readiness in relation to healthcare utilization during adult care.
Outcomes 1. To establish a longitudinal clinical cohort of patients with sickle cell disease (SCD) to serve as a research resource to facilitate evaluation of health outcomes in SCD from pediatric care into adulthood.
2. To facilitate the collection of biological samples from patients with SCD to be used in future studies investigating genetic and epigenetic contributions to disease severity, response to treatment, and morbidity and mortality.
Data Location St. Jude Children's Research Hospital
Biospecimen Available DNA; Plasma; Urine; Cell;
Data Consent Access requests from non-SCCRIP investigators for combined genetic and phenotypic data for hypothesis-driven research may be approved after completion of a concept proposal
Biospecimen Consent Future research with subjects’ biospecimens and the potential risks to loss of privacy
Contact Consent Yes, with permission on consent
Genomic Data No
Age Range 0.5-99
No. Participants 1084
Inclusion Criteria Participant has a diagnosis of Sickle Cell Disease of any genotype
Exclusion Criteria Participant does not have a diagnosis of Sickle Cell Disease of any genotype
Study Documentation
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Forms
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   1. SCCRIP-Data-Tables-2017
   2. SCCRIP-CRF-Final-2019

Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease SCD_DIAG
SCD_TYPE
Data ElementVariables
Fever
HIV Infection
Immune Problem
Infection
Vaccination DtaP/Tdap
Hepatitis A
Hepatitis B
Influenza Vaccine in 2017
Meningococcal
MMR (Measles, Mumps, & Rubella)
Pneumococcal 13-valent conjugate
Pneumococcal 23-polyvalent
Pneumococcal 7-valent
Data ElementVariables
Adverse event
Death Date of Death
survival status
Disability Status
Hospitalization
Medical Event
Serious Adverse Event
Data ElementVariables
Behavior BASC-2 Parent
BASC-2 Self
BASC-2 Teacher
Behavior Rating Inventory of Executive Function (BRIEF) - Adult Self
Brief Parent
BRIEF Teacher
Cognition BRACKEN
BSI
Caregiver Questionnaire
CPT II
DKEFS
NEPSY II
WAIS-IV
Wechsler Abbreviated Scale of Intelligence (WASI) -II
WISC-IV
WJ-III ACH
WPPSI-IV
WRAML-2
WRAVNA
Developmental Developmental
Motor Berry VMI
Grooved Pegboard
Sensation
Data ElementVariables
Cardiovascular
Digestive
Genitourinary
Lymphatic Procedure for splenectomy
Splenectomy Performed
Type of splenectomy
Musculoskeletal
Ocular
Respiratory
Surgery History
Data ElementVariables
Address
Age age
Age of Completion of Socio-Demographic CRF
Ethnic Group Ethnicity
Gender Sex
Language
National Origin
Nuclear Family
Race Race
Data ElementVariables
Annual Income Total Household Income in the Past Year
Education Education
Employment Status Employment Status
Household Number of People in Household (Including Respondent)
Insurance Health Insurance Status
Marital Status Living Arrangement
Marital Status
Data ElementVariables
Facility Type
Provider Type
Quality of Care
Visit Frequency of Utilization
Reason for ED Visit or Admission
Type of visit
Data ElementVariables
Final Diagnosis
Hospitalization hospital location
Distance from Clinic (Drive Time1)
ICU
Data ElementVariables
Abdomen
Bone CT DEXA
Brain
Chest
Data ElementVariables
Electrocardiogram (ECG) EKG impression
Data ElementVariables
Brain Brain MRA Result
Brain MRI Result
Heart MRI, Heart
Hip Hip MRI Results
Liver MRI, Liver
Data ElementVariables
Brain Transcranial doppler ultrasound - Overall Result
Data ElementVariables
Cognitive Functioning
Emotional Functioning
Physical Functioning Fatigue Module Total Scale Scores
School Functioning Core Assessment Total Scale Scores
Social Functioning
Data ElementVariables
Blood Differential Test CBC
Reticulocyte Count
Blood Gases Pulse 02 Sat
Blood Smear
Blood Typing Parvovirus IgG
Parvovirus IgM
Coagulation Test
Complete Blood Count
Comprehensive Metabolic Panel (CMP) 25-OH Vitamin D (ng/mL)
Blood Chemistry / CMP
BNP (B-type natriuretic peptide)
Erythropoietin Level (units/mL)
hs-CRP
Result
Total Calcium PTH (mg/dL)
Uncorrected GFR Result (mL / min / sqm)
Enzyme
General Parathyroid Hormone Intact Serum (pg/mL)
Hemoglobin Electrophoresis Genotype
Hemoglobin Fractionation
Iron
Data ElementVariables
Genitourinary Test
Urine Test Creatinine Urine Random (mg/dL)
Microalbumin Creatinine Ratio (mg/g Creatinine)
Microalbumin Urine Random (mg/dL)
Protein Creatinine Ratio (mg/g Creatinine)
Protein Urine Random (mg/dL)
Urine RBC
Urine Specific Gravity
Data ElementVariables
Abdomen
Anthropometrics Body Mass Index
Head Circumference
Height
Weight
Cardiovascular
Extremities
General Finding
Liver
Reproductive
Respiratory
Spleen
Vital signs Blood Pressure, DBP
Blood Pressure, SBP
Heart Rate
Respiratory Rate
Temperature Monitored, Core
Data ElementVariables
Pulmonary Function Test Pulmonary Function Test
Respiratory Test
Data ElementVariables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea HU maximum tolerated dose (MTD)
Start and stop dates for other medications
Start and stop dates of Endari
Start and stop dates of hydroxyurea
Medication
Neurologic Medication History
Pain
SCD Medication
Sildenafil
Supplements
Data ElementVariables
Blood Transfusion Age at First PBRC Transfusion
Antibody
Facility
Product Transfused
Reason
Transfusion Date
Transfusion Method
Units
Volume Removed
Volume Transfused
Chronic Transfusion Indication for chronic transfusion
Start and stop dates of chronic transfusions
Transfusion Complications
Data ElementVariables
Conditioning
Transplantation BMT Date
History of BMT
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