Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)

NCT02824471 | Recruiting

• 1 other identifier: 05-14-07C
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Biofluidic Chip Technology

Outcome Measures

Primary Outcomes (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.

  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.

  2 years

Secondary Outcomes (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.

  2 years

Study Arms (2)

Minor SCD Group, Ages 12-17

No Intervention. Use of discarded blood/tissue only

Other: SCD Group

Adult SCD. Ages 18+

No Intervention. Use of discarded blood/tissue only

Other: SCD Group

Interventions

SCD Group OTHER

No Intervention. Use of discard blood/tissue

Adult SCD. Ages 18+; Minor SCD Group, Ages 12-17

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (101)

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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.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Amma Owusu-Ansah, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umut Gurkan, PhD

CONTACT

(216) 368-6447; umut@case.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: July 6, 2016
• Study Start: October 1, 2014
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)