An observational study in Tinea Unguium and Onychomycosis, sponsored by National Cheng-Kung University Hospital. Completed. Per ClinicalTrials.gov, last updated 2014-10-21.
Sponsored by National Cheng-Kung University Hospital · Observational
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.
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.
152 studies on the registry are indexed under Onychomycosis; 14 are open to participants now.
This study's enrollment of 32 is below the median of 75 across 10 observational studies indexed under Onychomycosis.
Browse Onychomycosis studies →National Cheng-Kung University Hospital is the lead sponsor of 276 studies on the registry; 71 are open to participants now.
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The subject were suspect onychomycosis and treatment at National Cheng Kung University Hospital.
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Exclusion Criteria:
Difficult in regular diagnosis specimens, assistance with array.
Device: Array
Applications of oligonucleotide array in diagnosis.
Oligonucleotide Array Detection Resluts
The species of pathogen provide by array method.
Time frame: 1 weeks
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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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