Oral CancerNCT04955197
Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions
An observational study of Oral Cancer and Diagnoses Disease, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Diagnoses Disease
- What is being tested?
- exfoliated cytology
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Gihane madkour, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 11865
alaa elnaggar, Master, 01007802767, alaa_hassan@dentistry.cu.edu.eg
About this study
Official title: Accuracy of Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions
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.
Read the detailed 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 .
- Conditions
- Oral Cancer, Diagnoses Disease
- Being tested
- exfoliated cytology
- Keywords
- diagnosis, screening
- Medical subject headings
- Mouth Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exfoliated cytologyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: exfoliated cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mostafa Hassan Elnaggar, Cairo University
- Investigators
- alaa elnaggar, MSD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955197
- Sponsor's protocol ID
- Cancer screening
- Status last verified
- May 2022
- First submitted
- 4 Jul 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21552400
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions
- ClinicalTrials.gov ID
- NCT04955197
- Acronym / sponsor ID
- Cancer screening
- Conditions
- Oral Cancer, Diagnoses Disease
- Keywords
- diagnosis, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the histo-pathological picture | – | Diagnostic Test: exfoliated cytologyIn 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- • Individuals who had a recent viral infection or had undergone radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exfoliated cytologyMicronuclei (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 | Diagnostic test | the histo-pathological picture |
Primary outcome
Micronuclei presence
Time frame: 5 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 21552400Jadhav 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gihane madkour, professor contact
alaa elnaggar, MSD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer and Diagnoses Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alaa elnaggar, MSD (01007802767, alaa_hassan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micronuclei presence (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.