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Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)

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ClinicalTrials.gov Identifier: NCT02824471
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
Jane Little, University Hospitals Cleveland Medical Center

Brief Summary:

'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red cell membrane properties, shape, and density, and subsequent critical changes in inflammatory cell and endothelial cell function. Our goal is to understand the impact of CMA abnormalities in SCD, by interrogating a number of recognized interactions in a range of clinical phenotypes.

To date, correlative studies in SCD, by us and others, have range between clinical reports, based on tests, interventions, and chart review of individuals or groups of individuals and, at the other extreme, identification of functional gene polymorphisms based on population studies. The investigators wish to augment these studies through a systematic examination of cellular membrane properties and activation status. Of hematologic disorders, SCD may be unusually susceptible to such an examination.


Condition or disease Intervention/treatment
Sickle Cell Disease Other: SCD Group

Detailed Description:
Novel biofluidic chip technology can investigate surface characteristics that are typically measured with conventional techniques, such as fluorescent activated cell sorting (FACS), immunohistochemistry, or microscopic imaging methods. In FACS, cells of interest are isolated, extensively processed, incubated with a fluorescent-labeled antibody and sorted by optical recognition. In the proposed SCD biofluidic chip (SCD biochip), the interrogating antibody coats the microchannel surface and captures the cell population(s) of interest, without processing, incubation, or in vitro manipulation. The SCD biochip can also quantitate cellular adherence to experimental biological surfaces that are comprised of subcellular components. The SCD biochip is technically simple and experimentally flexible, whereby the population of interest is retained on the chip and quantitated in situ. The microchip system allows retrieval of viable isolated cells for potential downstream processing, analysis, and in vitro culture.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sickle Cell Disease (SCD) Biochip': Towards a Simple and Reliable Way to Monitor Sickle Cell Disease
Study Start Date : October 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Minor SCD Group, Ages 12-17
No Intervention. Use of discarded blood/tissue only
Other: SCD Group
No Intervention. Use of discard blood/tissue

Adult SCD. Ages 18+
No Intervention. Use of discarded blood/tissue only
Other: SCD Group
No Intervention. Use of discard blood/tissue




Primary Outcome Measures :
  1. Develop an SCD Biochip with which to examine key cellular properties and interactions, including RBC and WBC cellular, adhesive, and inflammatory properties, and circulating endothelial and hematopoietic precursor cell characteristics. [ Time Frame: 2 years ]
    Red and white cell adhesion to biomolecules (e.g. laminin, fibronectin, and selectins) will be measured on a microfluidic device, the SCD Biochip. Adhesion will be measured under normal oxygen and low oxygen conditions. Adhesions will be assessed relative to clinical findings, such as hematology parameters, and evidence for vaso-occlusion, pain, inflammation, and vasculopathy in patients with sickle cell disease.endothelial and hematopoietic precursor cells based on membrane properties and adhesion.


Secondary Outcome Measures :
  1. Correlate SCD Biochip function in heterogeneous SCD populations, including HbSS and HbSC at a range of ages, and in those with acute and chronic complications and compared with normal controls. [ Time Frame: 2 years ]
    The investigators will examine and validate clinical correlations with these cellular/membrane properties in larger populations of SCD, across a range of phenotypes, using our simple rapid flexible SCD Biochip platform.


Biospecimen Retention:   Samples Without DNA
This is a non-treatment study. The investigators will utilize the leftover blood or cast-off collected from the same blood that will be drawn during participants standard-of-care outpatient or hospital visit.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children (≥12 years old) and adults with SCD, including HbSS or compound heterozygus HbSC- or HbSβ- thalassemia will be offered participation. Control samples (HbAA) may be obtained from healthy volunteers.
Criteria

Inclusion Criteria

  • Male or female ≥12 years of age at the time of consent (enrollment).
  • Documentation Sickle Cell Disease, including HbSS or compound heterozygus HbSC- or HbSβ- thalassemia diagnosis as evidenced by one or more clinical features.
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria

  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824471


Contacts
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Contact: Alycia Slaton, RN, CCRC 216-286-0756 alycia.slaton@uhhospitals.org
Contact: Umut Gurkan, PhD (216) 368-6447 umut@case.edu

Locations
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United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jane Little, MD    216-844-1272    jane.little@uhhospitals.org   
Contact: Umut A Gurkan, Ph.D.    216) 368-6447    umut@case.edu   
Principal Investigator: Jane A Little, MD         
Sponsors and Collaborators
Jane Little
Case Western Reserve University
Investigators
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Principal Investigator: Jane Little, MD University Hospitals Cleveland Medical Center

Publications:
Ayyappan, S., et al., Renal Disease in Sickle Cell: Clinically Varied and Associated with Increased Mortality, in American Society of Hematology 2012: Atlanta Georgia

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Responsible Party: Jane Little, Director, Adult Sickle Cell Disease Clinic, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02824471     History of Changes
Other Study ID Numbers: 05-14-07C
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jane Little, University Hospitals Cleveland Medical Center:
Sickle Cell Disease
Biofluidic Chip Technology
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn