Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions

NCT04955197 | Unknown

• 1 other identifier: Cancer screening
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diagnosis; screening

Outcome Measures

Primary Outcomes (1)

• Micronuclei presence

  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.

  5 minutes

Study Arms (1)

the histo-pathological picture

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

Diagnostic Test: exfoliated cytology

Interventions

exfoliated cytology DIAGNOSTIC_TEST

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

the histo-pathological picture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with clinically normal oral mucosa and no evidence of any cancer risk factor as smoking and alcohol consumption.Participants with clinically normal oral mucosa and with evidence of any cancer risk factor as smoking and alcohol consumption. Participants with potentially malignant (leukoplakia, oral lichen planus, smoker keratosis and erythroplakia) Participants diagnosed with malignant disorders. • All age range will be included irrespective of their sex.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11865, Egypt

RECRUITING

Related Publications (1)

• Jadhav 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 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Disease

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• alaa elnaggar, MSD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

alaa elnaggar, MSD

CONTACT

01007802767; alaa_hassan@dentistry.cu.edu.eg

Gihane madkour, professor

CONTACT

gihanemadkour@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 8, 2021
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

EG (1)