ScabiesNCT02254564
PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
An observational study of Scabies, run by Seton Healthcare Family at 5 sites in United States.
Trial summary
The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Scabies
- How many people
- 17 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2014to 31 Oct 2017
- 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: Patients will be recruited upon identifying of scabies by microscopy or when a scraping is performed for suspected tinea or demodex folliculitis
Who may be able to join
- 1. Male/Female of all ages whose standard clinical treatment produces one or more of the following:
- Slides from skin scrapings containing scabies mites, eggs, and/or fecal material
- Slides from skin scrapings of suspected tinea
- Slides from skin scrapings of demodex mites
Who cannot join
- 1. Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Seton Family of Hospitals- Trinity and Hays Clinic
Austin, Texas, 78701
University Medical Center Brackenridge and Paul Bass Clinic
Austin, Texas, 78701
University of Texas Physicians at Trinity
Austin, Texas, 78701
Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children
Austin, Texas, 78723
Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic
Lockhart, Texas, 78644
About this study
The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.
Read the detailed description
The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.
- Conditions
- Scabies
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive Scrapings | Skin scrapings that are positive for scabies | |
| Negative Controls | collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScabiesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dayna Diven, Seton Healthcare Family
- Investigators
- Dayna Diven, MD, Principal investigator, Seton Healthcare Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254564
- Sponsor's protocol ID
- Scabies 1
- Status last verified
- Jun 2018
- First submitted
- 29 Sep 2014
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
- ClinicalTrials.gov ID
- NCT02254564
- Acronym / sponsor ID
- Scabies 1
- Conditions
- Scabies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 2 Oct 2014 (estimated)
- 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.
The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.
Detailed description
The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Scrapings | – | –Skin scrapings that are positive for scabies |
| Negative Controls | – | –collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited upon identifying of scabies by microscopy or when a scraping is performed for suspected tinea or demodex folliculitis
Key inclusion criteria (4 listed)
- 1. Male/Female of all ages whose standard clinical treatment produces one or more of the following:
Key exclusion criteria (1 listed)
- 1. Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Dayna Diven, MD principal investigator
Seton Healthcare Family
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scabies, run by Seton Healthcare Family at 5 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 4 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: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR (time frame: 1 year). 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 3 Jul 2018.