ClinicalTrials.gg
CompletedNCT05730855Updated Sep 13, 2023

Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

An observational study in Potentially Malignant Lesions, Oral Lichen Planus and Leukoplakia, Oral, sponsored by Fayoum University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Fayoum University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 35 studies in Lichen Planus, Oral with a site in Egypt — 5 open to participants now, 7 under way, 2 of them phase 3. Lichen Planus, Oral · Egypt.

Enrollment
10th of 12
45 · median 70
Started
2022
with 2 others
Observational
12 of 35
1 open now
Registered
15th of 35
by date
Lead sponsor
3 of 35
Fayoum University

Among the 35 studies in Lichen Planus, Oral with a site in Egypt, this one is the 10th largest by enrollment of the 12 observational ones that give a count, is one of 3 that started in 2022, is one of 12 observational ones, and was the 15th registered.

Lichen Planus, Oral

142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.

Browse Lichen Planus, Oral studies →

Open to participants now

5 of the 35 studies in Lichen Planus, Oral with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 14 Lichen Planus, Oral studies recruiting now, 10 (71%) set no upper age limit and 2 (14%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: all sexes · healthy volunteers too.

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02

Study summary

The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.

03

Conditions studied

  • Potentially Malignant Lesions
  • Oral Lichen Planus
  • Leukoplakia, Oral

Keywords

  • lncRNA DQ786243
  • saliva
  • oral potentially malignant lesions
  • miRNA146a
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Egyptian Population

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

  • participants will be divided into 3 groups:

Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion criteria

Exclusion Criteria:

  • Subjects taking any drugs inducing any changes that could affect the salivary flow.
  • Pregnant females.
  • Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
  • Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • Oral Lichen Planus

    Diagnostic Test: Real-time Polymerase Chain Reaction technique

  • Leukoplakia

    Diagnostic Test: Real-time Polymerase Chain Reaction technique

  • Healthy control

    Diagnostic Test: Real-time Polymerase Chain Reaction technique

Interventions

  • Diagnostic testReal-time Polymerase Chain Reaction technique

    Real-time Polymerase Chain Reaction technique

06

What researchers measure

Primary outcomes

  1. salivary expression of lncDQ786243 in OLP, Leukoplakia, control

    Time frame: 2 months

Secondary outcomes

  1. salivary expression of miRNA146a in OLP, Leukoplakia, control

    Time frame: 2 months

07

Study locations

1 site
  • Fayoum University
    Fayoum, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Dec 2022, 1 month.

Of 15 observational studies under Lichen Planus, Oral, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 1 month is below that.

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

Registered
Feb 7, 2023
First posted
Feb 16, 2023
StartActual
Nov 1, 2022
Primary completionActual
Dec 24, 2022
CompletionActual
Jan 23, 2023
Last update
Sep 13, 2023
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 Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05730855
Lead sponsor
Fayoum University
Responsible party
Salsabeel (Lecturer, Fayoum University) — Principal investigator
First posted
Feb 16, 2023
Start date
Nov 1, 2022
Primary completion
Dec 24, 2022
Completion
Jan 23, 2023
Last update
Sep 13, 2023

Oversight

Data monitoring committee
Yes
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 Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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