Clinical trial · Observational
Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions
Accuracy of Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions
- 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)
Micronuclei have been used since 1937 as an indicator of genetic toxic exposure due to their association with chromosomal alterations. They can be detected in exfoliated cells and used as an indicator of recent DNA injury within oral mucosa. The buccal epithelial cells are first to be interacted with the cancer compounds such as tobacco (nicotine), which in turn induces the frequency of micronuclei under the influence of saliva. The exfoliated cell micronuclei assay involves microscopic analysis of oral smears to determine the prevalence of micro-nucleation. The assay is reliable and technically easy to perform, noninvasive and sensitive with limited cost.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnoses Disease | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exfoliated cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- the histo-pathological picture
- description
- In the present study, the exfoliated cytology of group II and III will be compared to the histo-pathological picture of the lesion "reference standard". That is because the histopathology analysis is the definitive diagnosis of oral mucosal lesions
- interventionNames
- Diagnostic Test: exfoliated cytology
Primary outcomes (1)
- measure
- Micronuclei presence
- timeFrame
- 5 minutes
- description
- a sensitive indicators of genetic damage. They are usually found in the basal cells of epidermis and are shed as exfoliated cells on maturation. Hence micronuclei assay can be used as monitoring of genetic damage, as it is increased in oral neoplastic conditions.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Control group I: Participants with clinically normal oral mucosa and no evidence of any cancer risk factor as smoking and alcohol consumption. * Control group II: Participants with clinically normal oral mucosa and with evidence of any cancer risk factor as smoking and alcohol consumption. * Compare group III: Participants with potentially malignant lesions * Compare group IV: Participants diagnosed with malignant disorders. * All age range will be included irrespective of their sex. Exclusion Criteria: * • Individuals who had a recent viral infection or had undergone radiation therapy. * Those patients were excluded from the control group who had any history of tobacco intake or alcohol consumption and under medications.
References
Publications (1)
- BACKGROUNDJadhav K, Gupta N, Ahmed MB. Micronuclei: An essential biomarker in oral exfoliated cells for grading of oral squamous cell carcinoma. J Cytol. 2011 Jan;28(1):7-12. doi: 10.4103/0970-9371.76941. PMID 21552400