ClinicalTrials.gg
CompletedNCT07270471Updated Dec 9, 2025

Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples.

An observational study in Dermatophytosis, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Sex
All
01

Study summary

Superficial fungal infections (onychomycosis, dermatophytosis, tinea, etc.) caused by dermatophytes are common in the general population, affecting 20-25% worldwide (1, 2). In our practice, the most frequently observed clinical presentation is onychomycosis, with a prevalence ranging from 2% to 16.7% (3). However, diagnosing this fungal infection is challenging due to its lack of specificity and the long culture turnaround time (up to one month). A molecular approach could overcome these two limitations.

Currently, upon sample receipt, a direct mycological examination is performed alongside culture on specific media. If culture is positive, species or genus identification is carried out. Thus, the current reference method is a positive direct examination and/or a positive dermatophyte culture. Over the past four years (2020-2023), 49.85% of samples analyzed in our laboratory were positive (direct exam ± culture).

Several PCR kits are available for molecular detection of dermatophytes in skin and keratinous samples, and initial studies report promising performance: sensitivity ranging from 78.5% to 96.5% and specificity from 89.1% to 100%.

The study aims to determine the role of molecular diagnostics in these mycodermatological conditions and to compare the performance of two commercial kits.

Primary objective:

Determine the diagnostic performance of two molecular techniques for detecting dermatophytes.

The reference technique (gold standard) will be the presence of dermatophytes established by direct fungal examination. If the direct examination is negative, fungal culture will be performed for confirmation.

Secondary objectives:

Compare the diagnostic performance of the two molecular biology kits. Compare the average turnaround time for results.

02

Conditions studied

  • Dermatophytosis

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03

In context

Tinea

39 studies on the registry are indexed under Tinea; 8 are open to participants now.

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Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients consulting at CHRU Nancy for suspected dermatophyte infection.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients consulting at CHRU Nancy for suspected dermatophyte infection.

Exclusion criteria

Exclusion Criteria:

  • out CHRU Nancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testPCR dermatophyte

    multiplex dermatophytes PCR

06

What researchers measure

Primary outcomes

  1. dermatophytes : yes / no and species involved

    Time frame: 1 month

07

Study locations

1 site
  • CHRU Nancy
    Vandœuvre-lès-Nancy, 54500, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2024 to primary completion in Nov 2025, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2025
First posted
Dec 8, 2025
StartActual
Dec 27, 2024
Primary completionActual
Nov 1, 2025
CompletionActual
Nov 20, 2025
Last update
Dec 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07270471
Responsible party
Anne DEBOURGOGNE (PU-PH, Central Hospital, Nancy, France) — Principal investigator
First posted
Dec 8, 2025
Start date
Dec 27, 2024
Primary completion
Nov 1, 2025
Completion
Nov 20, 2025
Last update
Dec 9, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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