Herpes SimplexNCT02685956

Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test

An observational study of Herpes Simplex, run by Vela Diagnostics at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated. Read more about this study

Who is it for?: Any age
Conditions the study is for: Herpes Simplex
What is being tested?: Vela Sentosa SA HSV1/2 Qualitative PCR Test
Type of treatment: Medical device
How many people: 2,295 participants
Where: 9 sitesUnited States
Study dates: Apr 2016to 7 Apr 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Child, Adult, Older adult

Study population: Male and females with genital or oral lesions to be tested for HSV 1/2 infection.

Who may be able to join

Sample was taken from a lesion from an internal or external oral or genital site.
Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.
The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.
Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.
There is sufficient residual sample to perform both test and reference assays.

Who cannot join

Sample leaked during shipment or storage prior to assay.
Sample has undergone more than 1 freeze-thaw cycle before testing;
Sample eluent is not clear after centrifugation (refer to section 6.3.1).
Sample ID is missing or ambiguous.
Sample is collected using alginate calcium swab.
Sample handling and storage requirement in section 5.4 not followed

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Cleveland Clinic
Cleveland, Ohio, 44195
Geisinger Health
Danville, Pennsylvania, 17822
BioReference Labs
Elmwood Park, New Jersey, 07407
Quest Diagnostics
Horsham, Pennsylvania, 19044
MedFusion
Lewisville, Texas, 75067
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Beaumont Health
Royal Oak, Michigan, 48073
Baystate Health
Springfield, Massachusetts, 01199
Tampa General Hospital
Tampa, Florida, 33606

Other trials in United States

About this study

The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.

Read the detailed description

This study will utilize residual samples from male and female patients with signs and symptoms of oral or genital HSV infections. Genital samples will include internal and external genital lesions such as those collected from lesions of the anus, buttocks, vagina, labia, or penis. Oral samples will include those collected from lip, gum, and mouth lesions. For concordance testing, the sample size is based on historical study design and estimates of the expected prevalence of HSV1 and/or HSV2 in the population enrolled.

Conditions: Herpes Simplex
Being tested: Vela Sentosa SA HSV1/2 Qualitative PCR Test
Medical subject headings: Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vela Sentosa SA HSV1/2 Qualitative PCR TestDevice
Also called Sentosa HSV Assay
medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test

Study groups in NCT02685956
Study group	Role	What they receive
Vela Sentosa SA HSV1/2 PCR Test		Male and female subjects of any age with sample collected from a lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection. Receives: Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).
Measured: within 60 days of last sample enrollment
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
Study asses Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).
Measured: within 60 days of last sample enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20167 Apr 2017

First posted19 Feb 2016 (estimated)
Study startApr 2016
Primary completion7 Apr 2017
Study completion7 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Herpes SimplexStudies 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: Other
Time perspective: Prospective
Enrolment: 2,295 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02685956
Sponsor's protocol ID: Vela Sentosa HSV Study
Status last verified: May 2020
First submitted: 10 Feb 2016
Last updated: 5 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
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Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection

All Herpes Simplex trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
ClinicalTrials.gov ID: NCT02685956
Acronym / sponsor ID: Vela Sentosa HSV Study
Conditions: Herpes Simplex
Study type: Observational
Recruitment status: Completed
Enrolment: 2,295 participants (actual)
Lead sponsor: Vela DiagnosticsIndustry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: 7 Apr 2017 (actual)
Study completion: 7 Apr 2017 (actual)
First posted: 19 Feb 2016 (estimated)
Results: Posted 5 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Vela Sentosa SA HSV1/2 PCR Test	–	Device: Vela Sentosa SA HSV1/2 Qualitative PCR TestMale and female subjects of any age with sample collected from a lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Male and females with genital or oral lesions to be tested for HSV 1/2 infection.

Key inclusion criteria (5 listed)

Sample was taken from a lesion from an internal or external oral or genital site.
Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.
The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.
Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.
There is sufficient residual sample to perform both test and reference assays.

Key exclusion criteria (6 listed)

Sample leaked during shipment or storage prior to assay.
Sample has undergone more than 1 freeze-thaw cycle before testing;
Sample eluent is not clear after centrifugation (refer to section 6.3.1).
Sample ID is missing or ambiguous.
Sample is collected using alginate calcium swab.

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
Vela Sentosa SA HSV1/2 Qualitative PCR TestAlso: Sentosa HSV Assaymedical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test	Device	Vela Sentosa SA HSV1/2 PCR Test

Primary outcome

Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
Time frame: within 60 days of last sample enrollment
Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
Time frame: within 60 days of last sample enrollment
Study asses Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).

Results and safety

Results posted to the registry on 5 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Lesions	317	317
Anogenital Lesions	1,978	1,978

Primary outcome: Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test

Time frame: within 60 days of last sample enrollment. Count of participants. Unit: Participants

Measure	Anogenital Lesions With POSITIVE HSV1 ELVIS Result n = 290	Anogenital Lesions With Negative HSV1 ELVIS Result n = 1291
HSV-1 POSITIVE by SA201 HSV-1/2 PCR Test	281	54
HSV-1 NEGATIVE by SA201 HSV-1/2 PCR Test	9	1237

Population analysed: Analysis group included samples from 290 anogenital and 1291 anogenital lesions tested for HSV1 using the ELVIS HSV ID and D3 Typing Test System (N=1581). A further 397 that tested HSV2 positive by ELVIS were excluded from the HSV1 analysis.

Primary outcome: Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test

Time frame: within 60 days of last sample enrollment. Count of participants. Unit: Participants

Measure	Anogenital Lesions With POSITIVE HSV2 ELVIS Result n = 397	Anogenital Lesions With NEGATIVE HSV2 ELVIS Result n = 1581
HSV-2 POSITIVE by SA201 HSV-1/2 PCR Test	391	147
HSV-2 NEGATIVE by SA201 HSV-1/2 PCR Test	6	1434

Population analysed: Analysis group included samples from N=1978 anogenital lesions tested for HSV2 using the ELVIS HSV ID and D3 Typing Test System.

Adverse events

Time frame: This trial utilized remnant laboratory specimens and all results were monitored for accuracy and adverse events upon the completion of the testing phase of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Lesions	0 of 0	0 of 0	0
Anogenital Lesions	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Vela Diagnostics WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Herpes Simplex

RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection

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.

Shaw Chiat Hong study director

Vela Diagnostics

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Herpes Simplex, run by Vela Diagnostics at 9 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test (time frame: within 60 days of last sample enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02685956.

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 5 Jun 2020.