Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:35 AM
Study NCT ID:
NCT07416318
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unveiling the Protein Expression Patterns in Oral Lichen Planus and Leukoplakia Through Comparative Salivary Proteomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}, {'id': 'D007972', 'term': 'Leukoplakia, Oral'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007971', 'term': 'Leukoplakia'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Unstimulated saliva samples collected from participants diagnosed with Oral Lichen Planus, Oral Leukoplakia, and healthy controls will be retained. Samples will be collected under standardized conditions, pooled within their respective study groups, and stored under appropriate laboratory conditions until proteomic analysis. The retained biospecimens will be used for nano-liquid chromatography coupled with tandem mass spectrometry (nLC-MS/MS) and label-free protein quantification to characterize salivary proteome profiles.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative differences in salivary protein expression profiles between OLP, OL, and healthy control groups measured using label-free nLC-MS/MS proteomic analysis.', 'timeFrame': 'Baseline (single study visit during saliva sample collection; no longitudinal follow-up)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proteomics', 'Oral Lichen Planus', 'Oral Leukoplakia', 'Saliva', 'Pathogenesis', 'Biomarker'], 'conditions': ['Saliva', 'Oral Lichen Planus', 'Oral Leukoplakia', 'Proteomics']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare salivary proteome profiles in patients with Oral Lichen Planus (OLP), Oral Leukoplakia (OL), and healthy individuals without oral mucosal disease. The main questions it aims to answer are:\n\n1. Do salivary protein expression patterns differ between patients with OLP, OL, and healthy controls?\n2. Can specific differentially expressed proteins serve as potential biomarkers for distinguishing OLP and OL from each other and from healthy individuals?\n\nResearchers will compare salivary proteomic profiles from patients with OLP, patients with OL, and healthy controls to determine whether measurable differences in protein expression exist between the groups. Participants will:\n\n1. Provide unstimulated saliva samples collected as part of the study protocol.\n2. Undergo grouping based on clinical diagnosis (OLP, OL, or healthy control), after which samples will be pooled and analyzed using nano-liquid chromatography coupled with tandem mass spectrometry (nLC-MS/MS) and label-free protein quantification methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '29 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of individuals diagnosed with Oral Lichen Planus (OLP), individuals diagnosed with Oral Leukoplakia (OL), and healthy volunteers without oral mucosal disease. Participants were recruited from patients presenting for clinical evaluation and routine care, and were assigned to one of three cohorts based on clinical examination and diagnosis. The control group included individuals with clinically normal oral mucosa and no history of oral mucosal pathology.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Saliva samples from patients diagnosed with either OLP or OL were included in the study group.\n* Saliva samples from individuals with no dermatological or systemic diseases and no lesions in the oral mucosa were included in the control group.\n\nExclusion Criteria:\n\n* Patients who were using corticosteroids or retinoids that could affect the mucosa either locally or systemically were excluded from the study.\n* Patients with hyposalivation or with any conditions or medications that could cause reduced salivary flow were also excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07416318', 'briefTitle': 'Unveiling the Protein Expression Patterns in Oral Lichen Planus and Leukoplakia Through Comparative Salivary Proteomics', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Salivary Proteomic Comparison of Oral Lichen Planus and Oral Leukoplakia', 'orgStudyIdInfo': {'id': '2024/495'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral Lichen Planus'}, {'label': 'Oral Leukoplakia'}, {'label': 'Control Patients with Healthy Oral Mucosa'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alican Kuran', 'investigatorAffiliation': 'Kocaeli University'}}}}