Oral Cancer Clinical Trial
Official title:
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
NCT number | NCT03682562 |
Other study ID # | N1P1H1D1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2019 |
Est. completion date | March 10, 2020 |
Verified date | July 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.
Status | Completed |
Enrollment | 93 |
Est. completion date | March 10, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Patients in this study will be divided into three groups: Group I: Patients diagnosed histopathologically with oral cancer recruited from the National Cancer Institute, who have yet to receive treatment. Group II: Healthy Controls Inclusion Criteria: - No visible oral lesions as detected by conventional oral examination - Good oral hygiene, with healthy gingival tissues - Non-smokers - No systemic disease Group III: Patients diagnosed with oral lichen planus according to the modified WHO (van der Meij and van der Waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry - Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in DNA Integrity Index | The DNA integrity will be compared between the three group to determine whether there is a difference between them in that aspect or not | 1 month after the end of patient recruitment |
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