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

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Brief Title

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

Official Title

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

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 Type

Observational

Primary Outcome

Difference in DNA Integrity Index

Condition

Oral Cancer

Intervention

DNA Integrity Index

Study Arms / Comparison Groups

 Oral Cancer
Description:  Patients diagnosed clinically and histopathologically as having oral cancer.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

93

Start Date

September 15, 2019

Completion Date

March 10, 2020

Primary Completion Date

March 10, 2020

Eligibility Criteria

        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.

Gender

All

Ages

20 Years - 70 Years

Contacts

, ,

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT03682562

Organization ID

N1P1H1D1

Responsible Party

Principal Investigator

Study Sponsor

Cairo University

Study Sponsor

, ,

Verification Date

July 2020