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Trial record 64 of 11738 for:    Oral Cancer

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

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ClinicalTrials.gov Identifier: NCT03682562
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Noha Adel Azab, Cairo University

Tracking Information
First Submitted Date September 21, 2018
First Posted Date September 24, 2018
Last Update Posted Date January 31, 2019
Estimated Study Start Date March 15, 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2019)
Difference in DNA Integrity Index [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: September 21, 2018)
Difference in DNA Integrity Index [ Time Frame: 1 month after the end of patient recruitment ]
Change History Complete list of historical versions of study NCT03682562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Salivary Samples will be obtained for DNA extraction, Biosamples will be stored in -80 degrees after patient's consent
Sampling Method Non-Probability Sample
Study Population

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:

  • No smoking
  • No alcohol
  • No systemic disease; and who on conventional oral examination(National Institute of Dental and Craniofacial Research, 2013b) have:
  • No visible oral lesions on conventional oral examination .
  • Good oral hygiene. Group III: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically with oral lichen planus as stated by modified WHO criteria (van der Meij and van der Waal, 2003).
Condition
  • Oral Cancer
  • Oral Lichen Planus
  • Oral Leukoplakia
Intervention 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.

Study Groups/Cohorts
  • Oral Cancer
    Patients diagnosed clinically and histopathologically as having oral cancer.
    Intervention: Diagnostic Test: DNA Integrity Index
  • Premalignant Oral Lesions
    Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria
    Intervention: Diagnostic Test: DNA Integrity Index
  • Normal Subjects

    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.
    Intervention: Diagnostic Test: DNA Integrity Index
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 21, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03682562
Other Study ID Numbers N1P1H1D1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: 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
Responsible Party Noha Adel Azab, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date January 2019