Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

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

Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Official Title

Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Brief Summary

      This is a follow up study which aims to evaluate the correlation between several methylated
      genes (potential biomarkers) and oral cancers. A prospective case control trial is designed
      with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion
      or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the
      National Taiwan University Hospital Research Ethics Committee. After signing the informed
      consent, all subjects will receive an intraoral examination and followed by epithelial cells
      collection with oral swab. The gDNA will be extracted from the oral swab collected cells and
      followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be
      subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical
      sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis
      confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.

Study Type

Observational

Primary Outcome

DNA methylation

Condition

Oral Cancer

Study Arms / Comparison Groups

 normal oral mucosa
Description:

Publications

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

Recruitment Information

Estimated Enrollment

300

Start Date

April 18, 2016

Primary Completion Date

April 17, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Subject with age over 20.

          -  Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous
             lesion, and oral cancer) or subjects who have involved in the previous study
             (NCT01945697).

          -  Subjects agrees to sign the informed consent form.

        Exclusion Criteria:

          -  Pregnant woman.

          -  Subject disagrees to sign the informed consent form.

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 886-2-23123456, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT02902406

Organization ID

201601034RINB

Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital

Study Sponsor

, ,

Verification Date

September 2016