Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions

Oral Cancer Clinical Trial

Official title:

Accuracy of Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955197
• Other study ID #: Cancer screening
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: alaa elnaggar, MSD
• Phone: 01007802767
• Email: alaa_hassan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study will be held at the Faculty of Dentistry Cairo University and the NCI All the participants will be administrated a standardized questionnaire to obtain demographic data, medical records and any history of relevant risk factors. The detailed clinical examination will be performed on each patient to assess the site, size, and the clinical characteristics of the lesion as well as the extent of local infiltration (if any) and cervical lymph node metastases (if any).

The entire procedure will be explained to the patients and an informed consent will be obtained. The participants were asked to rinse their mouth thoroughly with tap water 2-3 times immediately before the sampling procedure to reduce the oral bacterial load. Pre-moistened separate wooden spatula was used to scrape the oral buccal mucosa cells (right and left buccal mucosal cells). The cells were then smeared over clean, coded glass slides. The slides were then air dried and fixed in fixative for 20 minutes and stained. Afterwards the glass slide was rinsed with aqua dest and dried in the air. The slides will be prepared for microscopic analysis The criteria parameters for identifying micronucleus:

• Rounded smooth perimeter suggestive of a membrane.

• Less than one-third the diameter of the associated nucleus, but large enough to discern shape and color.

• Staining intensity similar to the nucleus.

• Texture similar to the nucleus.

• Same focal plane as the nucleus.

• Absence of overlap with or bridge to the nucleus.

Dead or degenerating cells (karyolysis, karyorrhexis, nuclear fragmentation) were excluded from the evaluation. Incisional or excisional biopsy will be obtained from subjects diagnosed with premalignant lesions and histo-pathological examination will be performed as an additional supportive test .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnoses Disease
• Mouth Neoplasms
• Oral Cancer
• Precancerous Conditions

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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