Diagnoses DiseaseNCT03619798
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
An observational study of Diagnoses Disease, run by Silver Lake Research Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- HemoTypeSC
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Agrees to be enrolled (or has parent/guardian approval to be enrolled)
Who cannot join
- Previous sickle cell screening
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Silver Lake Research Corporation
Azusa, California, 91702
Erik Serrao, 310-387-2866, eserrao@silverlakeresearch.com
About this study
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
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.
- Conditions
- Diagnoses Disease
- Being tested
- HemoTypeSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoTypeSCDevice
Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive for Hemoblogin A, S, or C
Measured: Immediate (investigational test) to one week (reference test)
Negative for Hemoglobin A, S, or C
Measured: Immediate (investigational test) to one week (reference test)
Positive for Hemoglobin AA, AS, AC, SS, SC, or CC
Measured: Immediate (investigational test) to one week (reference test)
Negative for Hemoglobin AA, AS, AC, SS, SC, or CC
Measured: Immediate (investigational test) to one week (reference test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start3 Aug 2018
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silver Lake Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619798
- Sponsor's protocol ID
- HTSC111
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03619798
- Acronym / sponsor ID
- HTSC111
- Conditions
- Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Silver Lake Research CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Agrees to be enrolled (or has parent/guardian approval to be enrolled)
Key exclusion criteria (1 listed)
- Previous sickle cell screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoTypeSCPoint-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood | Device | – |
Primary outcome
Positive for Hemoblogin A, S, or C
Time frame: Immediate (investigational test) to one week (reference test)
Negative for Hemoglobin A, S, or C
Time frame: Immediate (investigational test) to one week (reference test)
Positive for Hemoglobin AA, AS, AC, SS, SC, or CC
Time frame: Immediate (investigational test) to one week (reference test)
Negative for Hemoglobin AA, AS, AC, SS, SC, or CC
Time frame: Immediate (investigational test) to one week (reference test)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnoses Disease, run by Silver Lake Research Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Serrao, PhD (3103872866, eserrao@silverlakeresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive for Hemoblogin A, S, or C (time frame: Immediate (investigational test) to one week (reference test)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.