NCT05403216

Brief Summary

On the basis of previous studies, a validation cohort will be established to explore the relationship between oral lichen planus and autoimmune thyroid diseases, and a disease efficacy prediction strategy can be formed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

March 13, 2022

Last Update Submit

September 20, 2025

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (2)

  • Oral lichen planus (OLP) lesions record

    Record changes of lesions based on the symptoms and signs of the oral lichen planus patient.

    1 year

  • Level of thyroid function and antibody

    The levels of thyroid hormone and thyroid autoantibodies in serum of OLP patients were detected.

    1 year

Study Arms (2)

OLP(-)

Oral lichen planus (OLP) with negative thyroid antibody group

OLP(+)

OLP with positive thyroid antibody group

Other: no intervention

Interventions

no interventionOTHER
OLP(+)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Oral lichen planus (OLP) patients

You may qualify if:

  • OLP patients without systemic disease

You may not qualify if:

  • OLP patients with severe periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310014, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy is the gold standard for the diagnosis of oral lichen planus. Without compromising the diagnosis, we collected oral mucosal tissue from biopsy of oral lichen planus patients.

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Qianming Chen, Dr.

    Zhejiang University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 13, 2022

First Posted

June 3, 2022

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)