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Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions

NCT04955197 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2022-05-25

No results posted yet for this study

Summary

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

  • Oral Cancer
  • Diagnoses Disease

Interventions

DIAGNOSTIC_TEST

exfoliated cytology

Micronuclei (MN) are small chromatin bodies in the cytoplasm formed by chromosome fragments or whole chromosomes that fail to be included in the nuclei during cell division. They are considered as 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. Consequently, detection of micronuclei in exfoliated cells indicates an increased risk for cancer

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • alaa elnaggar, MSD · Cairo University

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-09-01
Completion
2022-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955197 on ClinicalTrials.gov