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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270697
• Other study ID #: A-ER-101-336
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: October 17, 2014
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Atypically results by culture and microscopy

• Suspect tinea infection

Exclusion Criteria:

• Lost follow

• Not tinea unguium

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Onychomycosis
• Tinea Unguium

Intervention

Device:
• Array
Applications of oligonucleotide array in diagnosis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oligonucleotide Array Detection Resluts	The species of pathogen provide by array method.	1 weeks	No