Clinical trial · Observational
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
NCT03682562CI-TRIAL-00045976completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Leukoplakia | — | UNRESOLVED | — |
| Oral Lichen Planus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA Integrity Index | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Oral Cancer
- description
- Patients diagnosed clinically and histopathologically as having oral cancer.
- interventionNames
- Diagnostic Test: DNA Integrity Index
- label
- Premalignant Oral Lesions
- description
- Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria
- interventionNames
- Diagnostic Test: DNA Integrity Index
- label
- Normal Subjects
- description
- Patients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination have: * No visible oral lesions on conventional oral examination . * Good oral hygiene.
- interventionNames
- Diagnostic Test: DNA Integrity Index
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Patients in this study will be divided into three groups: Group I: Patients diagnosed histopathologically with oral cancer recruited from the National Cancer Institute, who have yet to receive treatment. Group II: Healthy Controls Inclusion Criteria: * No visible oral lesions as detected by conventional oral examination * Good oral hygiene, with healthy gingival tissues * Non-smokers * No systemic disease Group III: Patients diagnosed with oral lichen planus according to the modified WHO (van der Meij and van der Waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.