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NCT02641717 · ClinicalTrials.gov registry record · NA

Validity of Patient-Collected Wet Mounts

A NA study, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
NA
Development phase
77
Enrollment target

NCT02641717 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 77 participants.

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The verdict

NCT02641717, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
NA
Development phase
77 participants
Enrollment target

Study Summary

Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted disease clinic. Research Design/Plan: Prospective, non-randomized, non-blinded trial Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal discharge, odor and/or itching). Calculate concordance between clinician- and patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity, specificity, positive predictive value and negative predictive value of the patient-collected wet mount, using the clinician-collected specimens as the "gold standard." Clinical Relevance: A "wet mount," or microscopic examination, is commonly used to diagnose trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little information about patient-collected wet mounts exists in the literature. Self-collection by women before being seen by a clinician can increase the speed and efficiency of the visit. The method is highly acceptable to women. In the investigators' clinic, women routinely collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be burdensome.

Interventions

  • OTHER vaginal swab

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2015-11
Est. Completion 2016-08
Phase NA

What the Registry Record Tells You About NCT02641717

The ClinicalTrials.gov registry entry for NCT02641717 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which vaginal swab is the first listed.

NCT02641717 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02641717 about?

NCT02641717 is a clinical study titled "Validity of Patient-Collected Wet Mounts". Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted d...

What is the current status of trial NCT02641717?

This trial is currently completed. It is a NA study. The enrollment target is 77 participants. The study started on 2015-11. Estimated completion is 2016-08.

What interventions are being tested in trial NCT02641717?

The interventions under investigation include: vaginal swab (OTHER).

Who is sponsoring clinical trial NCT02641717?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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