An observational study in Oral Cancer, Oral Lichen Planus and Oral Leukoplakia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Cairo University · Observational
This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.
As stated by the U.S. Preventive Services Task Force and the National Institute of Dental and Craniofacial Research, the main screening test for oral cancer remains conventional oral examination of the oral cavity. Most cases of oral cancer are preceded by a clinically visible lesion. These lesions are called oral potentially malignant disorders. These are leukoplakia, erythroplakia, oral submucous fibrosis, oral lichen planus and discoid lupus erythematosis. Leukoplakia has a reported annual transformation rate of 2-3%, while OLP has a rate of 0.5% .
Full thickness tissue biopsy is the "gold standard" for diagnosing suspicious lesions should they be encountered during COE. However, oral biopsy is an invasive technique that can be challenging in sites as the floor of the mouth or the soft palate . The invasive nature of a biopsy also makes it unsuitable for cancer screening in high-risk populations.
Thus there is a need for a diagnostic aid that can help primary care providers determine which patients need to be biopsied or referred to a specialist.
Nucleic acids can be released actively or passively into the circulation by both living and dead cells, where the latter is considered the predominant source. Programmed cell death gives neatly digested DNA fragments of approximately 180 bp in length. In case of solid tumors, cell-free DNA is released through necrosis which generates longer DNA fragments due to haphazard and incomplete digestion of DNA. Thus, the integrity of the DNA fragment can determine its origin making DNA integrity a potential marker for oral cancer.
The DNA integrity index (DII) is the ratio between the longer DNA fragments to the shorter ones. A higher index has been reported in breast, prostate, liver and cervical cancer. Jiang et al. 2006 found that the DNA integrity index was significantly higher in oral cancer patients than in normal ones and reported a sensitivity and specificity values of 84.5% 83% respectively . The next step for such a marker would be early quantification of performance in clinical settings to determine if it is possible to extrapolate cut off values.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's enrollment of 93 is close to the median of 97 across 20 observational studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Leukoplakia, Oral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mouth Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Group I: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically as having oral cancer. Group II: (History and Clinical examination)
Patients who give a history of:
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:
Patients diagnosed clinically and histopathologically as having oral cancer.
Diagnostic Test: DNA Integrity Index
Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria
Diagnostic Test: DNA Integrity Index
Patients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination have: * No visible oral lesions on conventional oral examination . * Good oral hygiene.
Diagnostic Test: DNA Integrity Index
This test will be performed for ALL three groups: Sample collection: Patients will be given a sterile cup containing 5mL saline solution with which they will vigorously rinse their mouth while rubbing their tongues against the oral mucosa for 30 seconds, then spit it back into the cup. The solution will then be used for DNA extraction. DNA integrity analysis: The DNA integrity will be done through measuring a housekeeping gene using competitive polymerase chain reaction where the isolated DNA will be combined with DNA capture probes for sequence-specific DNA fragments. The DNA integrity index will be calculated as the ratio of the concentration of longer DNA fragments to the ratio of shorter ones.
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
Time frame: 1 month after the end of patient recruitment
Plan to share: Undecided — According to the mode of data entry, if it is solely numerical it can be more easily shared and deposited on repositories, however patient clinical photos may not be possible to share
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Mar 2020, 5 months.
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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