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

Completed

• Conditions: Oral Leukoplakia; Oral Cancer; Oral Lichen Planus
• Interventions: Diagnostic Test: DNA Integrity Index

• Registration Number: NCT03682562
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-24
• Study Start: 2019-09-15
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premalignant Oral Lesions	DNA Integrity Index	Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria
Normal Subjects	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.
Oral Cancer	DNA Integrity Index	Patients diagnosed clinically and histopathologically as having oral cancer.

Primary Outcome Measures

Name	Time	Method
Difference in DNA Integrity Index	1 month after the end of patient recruitment	The DNA integrity will be compared between the three group to determine whether there is a difference between them in that aspect or not

Trial Locations

Locations (1)

Faculty of Dentistry - Cairo University; 🇪🇬 Cairo, Egypt