Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens
1 other identifier
observational
32
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedOctober 21, 2014
October 1, 2014
1 year
October 16, 2014
October 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Oligonucleotide Array Detection Resluts
The species of pathogen provide by array method.
1 weeks
Study Arms (1)
Regular Diagnosis
Difficult in regular diagnosis specimens, assistance with array.
Interventions
Eligibility Criteria
The subject were suspect onychomycosis and treatment at National Cheng Kung University Hospital.
You may qualify if:
- Atypically results by culture and microscopy
- Suspect tinea infection
You may not qualify if:
- Lost follow
- Not tinea unguium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
* Nail Samples * Scrap Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tsung Chain Chang, PhD
National Cheng Kung University
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 16, 2014
First Posted
October 21, 2014
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2014
Last Updated
October 21, 2014
Record last verified: 2014-10