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

checkorphan
Learn more about:
Tongue neoplasm
Related Clinical Trial
The Oral Microbiome in OSCC The Link Between Periodontitis, Smoking and Oral Cancer Research on Optimization and Evaluation of Oral Cancer Screening Methods Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings Topical Aldara (Imiquimod) for Oral Cancer Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions LLL Phototherapy in Oral Lesions Resulting From Anti-neoplastic Treatment Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial Understanding Non-radiotherapy-based Development of Trismus Use of Ultrasound for Measuring Size of Oral Tongue Cancers Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients Oral Cancer Screening and Education in Hong Kong Evaluating Oral Visual Inspection in the Control of Oral Cancer Inductive Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients Effects of EMG Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection: a Randomized Clinical Trial Prevention of Oral DNA Damage by Black Raspberries Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma NBI in Oral Cavity Cancer Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer Physical Activities by Technology Help (PATH) Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients Patient Evaluation for Head and Neck Surgery Branch Studies Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy Prospective Analysis of Robot-Assisted Surgery Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Cigarette Smoking and Oral Microbiota Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line The Role of Lymphangiogenesis in Head and Neck Cancer Metastasis Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis Least Invasive Nonlinear Light Microscopy Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients Improving Access to Control of Diseases for Women IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Submandibular Gland Preservation in Neck Dissection uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression The Use of Functional Confections in Promoting Oral Health The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions Wild Type p53 Adenovirus for Oral Premalignancies Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Trial of IIb Preserving Neck Dissection Expression of Hypoxia-Inducible Factor-α in Oral Precancers and Cancers Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography Innovative Approach to Triage Oral Precancer The Role of SDF-1/CXCR4 in Metastasis of Oral Squamous Cell Carcinoma Rehabilitation Outcomes in Head and Neck Survivors Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions The Relation of Microtubule-Associated Protein 2 and Cell Migration Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study) Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue Oral Pathology Asynchronous Telementoring Pilot Study Polarized Reflectance Spectroscopy for Oral Lesions A Study of the Effects of PEITC on Oral Cells With Mutant p53 Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma The Role of microRNA-29b in the Oral Squamous Cell Carcinoma Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer – COOLS TRIAL Assessment of Mandibular Bone Invasion With MRI Using SWIFT Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients Epstein-Barr Detection in Oral Cancer Workplace Tobacco Cessation And Oral Cancer Screening Study Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer. Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies Effects of Mouth-opening Training on the Maximum Interincisal Opening Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy – 3-years Prospective Study Erlotinib Prevention of Oral Cancer (EPOC) Oral Cancer Screening in Mumbai, India by Primary Health Care Workers Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor. The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer. Validation of DNA Methylation Biomarkers for Oral Cancer Detection Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention Expression of VEGF-C and VEGF-CR in Oral Cancers and Premalignant Lesions PET/CT and Sentinel Node in Oral Cancer Validation of DNA Methylation Biomarkers for Oral Cancer Detection Web-based Education on Oral Cancer for Primary Care Physicians in Ohio Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients Using an APP in Post Oral Cancer Surgery to Affect Patients’ Needs and Quality of Life.

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