Skip to main content
OpenTrials
Completed

NCT Number: NCT02270697

Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens

The nail specimens from patients with suspect onychomycosis were analyzed. Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the array results with the regular methods by sensitivity, specificity, NPV and PPV.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The nail specimens from patients with suspect onychomycosis were analyzed.

Collection:

Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan.

Nail samples were collected as subungual scrapings, clippings, or curettings. Samples were immediately transported in sterile Eppendorf tubes at room temperature to the laboratory of Department of Dermatology, NCKUH, for KOH stain and routine fungal cultures.

Sample Prepare:

Each sample was cut into small pieces with a surgical blade and homogenization by 2-ml glass homogenizer. The suspension treated by lyticase at 37°C for 30 min and extracted DNA with Blood & Tissue genomic DNA kit.PCR program and array hybirdization same with previous study.

Analysis:

If the results between array and culture method, discrepant analysis with re-sequencing, KOH mount and the patient's outcome of after antifungal treatment. The performance evaluation of the array and culture methods with Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were calculated after discrepant analysis. Significant difference was estimated by Fisher's exact test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atypically results by culture and microscopy
  • Suspect tinea infection

Exclusion criteria

  • Lost follow
  • Not tinea unguium

Treatment and study plan

Array

Device

Applications of oligonucleotide array in diagnosis.

Primary outcomes

  1. Oligonucleotide Array Detection Resluts

    Time frame: 1 weeks

    The species of pathogen provide by array method.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 21, 2014
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.