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Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings

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ClinicalTrials.gov Identifier: NCT03619798
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Silver Lake Research Corporation

Study Description
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Brief Summary:
Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent in low-resource regions of the world, where newborn screening is rare due to the cost and logistical burden of laboratory-based methods. In many such regions, >80% of affected children die, undiagnosed, before the age of five years. A convenient and inexpensive point-of-care test for sickle cell disease is thus crucially needed. In this study we will conduct a blinded, multicenter, prospective diagnostic accuracy study of HemoTypeSC(TM), an inexpensive 15-minute point-of-care immunoassay for detecting sickle cell disease, hemoglobin C disease, and trait phenotypes in newborns, children, and adults.

Condition or disease Intervention/treatment
Diagnoses Disease Device: HemoTypeSC

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings: a Multi-Center
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: HemoTypeSC
    Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood

Outcome Measures
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Primary Outcome Measures :
  1. Positive for Hemoblogin A, S, or C [ Time Frame: Immediate (investigational test) to one week (reference test) ]
  2. Negative for Hemoglobin A, S, or C [ Time Frame: Immediate (investigational test) to one week (reference test) ]
  3. Positive for Hemoglobin AA, AS, AC, SS, SC, or CC [ Time Frame: Immediate (investigational test) to one week (reference test) ]
  4. Negative for Hemoglobin AA, AS, AC, SS, SC, or CC [ Time Frame: Immediate (investigational test) to one week (reference test) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newborns, children, and adults from neonatal intensive care clinics, maternity wards, and other clinics at various low-, medium-, and high-resource study centers in multiple countries.
Criteria

Inclusion Criteria:

  • Agrees to be enrolled (or has parent/guardian approval to be enrolled)

Exclusion Criteria:

  • Previous sickle cell screening
Contacts and Locations
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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): NCT03619798


Contacts
Contact: Erik Serrao, PhD 3103872866 eserrao@silverlakeresearch.com

Locations
United States, California
Silver Lake Research Corporation Recruiting
Azusa, California, United States, 91702
Contact: Erik Serrao    310-387-2866    eserrao@silverlakeresearch.com   
Sponsors and Collaborators
Silver Lake Research Corporation
More Information
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Responsible Party: Silver Lake Research Corporation
ClinicalTrials.gov Identifier: NCT03619798     History of Changes
Other Study ID Numbers: HTSC111
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Sickle Cell
Hemoglobin C Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn