- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682562
Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11553
- Faculty of Dentistry - Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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).
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oral Cancer
Patients diagnosed clinically and histopathologically as having oral cancer.
|
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. |
Premalignant Oral Lesions
Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria
|
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. |
Normal Subjects
Patients who give a history of:
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month after the end of patient recruitment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N1P1H1D1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Cancer
-
Royal Surrey County Hospital NHS Foundation TrustCompleted
-
Centre Francois BaclesseTerminatedCancer | Cognitive Function | Compliance | Oral TherapiesFrance
-
University of WashingtonBlaze Bioscience Inc.RecruitingStage III Lip and Oral Cavity Cancer AJCC v8 | Oral Cavity Squamous Cell Carcinoma | Stage I Lip and Oral Cavity Cancer AJCC v8 | Stage II Lip and Oral Cavity Cancer AJCC v8 | Stage IVA Lip and Oral Cavity Cancer AJCC v8United States
-
National Cancer Institute (NCI)CompletedLip and Oral Cavity Cancer | Oropharyngeal Cancer | Tongue Cancer | Oral LeukoplakiaUnited States
-
National Cancer Institute (NCI)CompletedLip and Oral Cavity Cancer | Oropharyngeal Cancer | Tongue Cancer | Stage 0 Lip and Oral Cavity Cancer | Stage 0 Oropharyngeal CancerUnited States
-
Dana-Farber Cancer InstituteCompletedBreast Cancer | Gastrointestinal Cancer | Oral Cancer Directed Therapy | Oral ChemotherapyUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedTongue Cancer | Lip and Oral Cavity Squamous Cell Carcinoma | Oral Cavity Verrucous Carcinoma | Stage 0 Lip and Oral Cavity CancerUnited States
-
University of British ColumbiaRecruiting
-
Centre Francois BaclesseLigue contre le cancer, FranceCompletedManagement of Oral Care and Cancer in Palliative SituationFrance
-
Istituto Scientifico Romagnolo per lo Studio e...Kessler FoundationUnknownCancer | Oral Drug AdministrationItaly
Clinical Trials on DNA Integrity Index
-
Assiut UniversityCompleted
-
University Hospital, AngersFrench Innovative Leukemia OrganisationUnknownAdult Acute Lymphoblastic LeukemiaFrance
-
Sunnybrook Health Sciences CentreMOUNT SINAI HOSPITAL; Princess Margaret Hospital, Canada; Trillium Health PartnersRecruiting
-
UMC UtrechtUnknownAcute Coronary Syndrome | Stable Angina PectorisNetherlands, Luxembourg
-
Medtronic VascularCompletedCoronary Artery DiseaseUnited States
-
Medtronic VascularCompletedCoronary Artery DiseaseUnited States
-
Emory UniversityCompletedCoronary Artery DiseaseUnited States
-
Ajou University School of MedicineMedtronicUnknownAcute Myocardial InfarctionKorea, Republic of
-
Riphah International UniversityCompleted
-
The University of Hong KongCompletedCoronary Artery DiseaseHong Kong