PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei

Completed

• Conditions: Scabies

• Registration Number: NCT02254564
• Lead Sponsor: Seton Healthcare Family

Brief 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.

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 Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study Start: 2014-10
• Study First Posted: 2014-10-02
• Primary Completion: 2017-08
• Study Completion: 2017-10-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR	1 year

Trial Locations

Locations (5)

Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic; 🇺🇸 Lockhart, Texas, United States

Seton Family of Hospitals- Trinity and Hays Clinic; 🇺🇸 Austin, Texas, United States

University Medical Center Brackenridge and Paul Bass Clinic; 🇺🇸 Austin, Texas, United States

University of Texas Physicians at Trinity; 🇺🇸 Austin, Texas, United States

Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children; 🇺🇸 Austin, Texas, United States