MedDataX Logo

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

NCT ID: NCT03619798

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-03

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sickle Cell Disease, Hemechip

NCT03948516

Sickle Cell Disease
COMPLETED

SCRIPT: Sickle Cell Risk in Pregnancy Tool

NCT06529042

Sickle Cell Disease Pregnancy, High Risk Pregnancy Complications
ENROLLING_BY_INVITATION

Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency

NCT06615024

Sickle Cell Disease and G6PD Deficiency
NOT_YET_RECRUITING

Screening for Renal Complications in Children and Young Adults With Major Sickle Cell Disease

NCT05211037

Anemia Sickle Cell Disease
COMPLETED NA

Carbon Monoxide Levels and Sickle Cell Disease Severity

NCT01547793

Sickle Cell Disease Sickle Cell Anemia Anemia, Sickle Cell
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnoses Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HemoTypeSC

Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Previous sickle cell screening
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Silver Lake Research Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Silver Lake Research Corporation

Azusa, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Erik Serrao, PhD

Role: CONTACT

[email protected]
3103872866

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Erik Serrao

Role: primary

[email protected]
310-387-2866

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HTSC111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CHOICES3: Sickle Cell Disease Parenting CHOICES
NCT05292781 ACTIVE_NOT_RECRUITING NA
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
NCT06979492 NOT_YET_RECRUITING PHASE4
Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
NCT02225132 COMPLETED PHASE1/PHASE2
Screening Patients With Sickle Cell Disease for Kidney Damage
NCT02239016 COMPLETED
Blood Sampling for Research Related to Sickle Cell Disease
NCT00542230 RECRUITING
Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada
NCT05506358 COMPLETED NA
Hydroxyurea for the Treatment of Patients With Sickle Cell Anemia
NCT00001197 COMPLETED PHASE2
Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
NCT02565082 COMPLETED NA
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
NCT05675436 ACTIVE_NOT_RECRUITING
Cooperative Assessment of Late Effects for SCD Curative Therapies
NCT05153967 RECRUITING
Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)
NCT03380351 COMPLETED
Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention
NCT06562439 NOT_YET_RECRUITING NA
The Influence of micro-and Macro Vascular Dysfunction on Clinical Severity in Adults With Sickle Cell Anemia (SS) and Sickle Cell Hemoglobin C Disease (SC)
NCT07277023 COMPLETED NA
Living With Sickle Cell Disease in the COVID-19 Pandemic
NCT04417673 COMPLETED
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
NCT06313398 RECRUITING EARLY_PHASE1
Development and Evaluation of an Information Management System and Communication System for Population-wide Point-of-care Infant Sickle Cell Disease Screening
NCT06563440 NOT_YET_RECRUITING NA
Decitabine for High-Risk Sickle Cell Disease
NCT01375608 COMPLETED PHASE2
Decision Aid for Therapeutic Options In Sickle Cell Disease
NCT02326597 COMPLETED NA
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
NCT05387564 COMPLETED NA
Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)
NCT05618301 COMPLETED PHASE1
Study of a Red Blood Cell Deformability Parameter in Patients With Sickle Cell Disease
NCT03977532 COMPLETED NA
Hemostasis in Sickle Cell Disease--Infancy to Adulthood
NCT00005703 COMPLETED
Cutaneous Hydration Assessment in SCD
NCT05210114 RECRUITING NA
Early Diagnosis of Sickle Acute Chest Syndrome Using a Combination of Plasma Bimarkers and Chest Imaging
NCT03478917 COMPLETED
Sickle Cell Disease Obstetric Multi-Disciplinary Care Programme
NCT05143021 ACTIVE_NOT_RECRUITING