NCT03682562

Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: —

Summary

This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.

Detailed description

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.

Conditions

• Oral Cancer
• Oral Lichen Planus
• Oral Leukoplakia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-15
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2018-09-24
• Last updated: 2020-07-15

Locations

1 site across 1 country: Egypt