Neoplasms

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Osteonecrosis

Precancerous Conditions

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bone Diseases

Necrosis

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Buccal mucosa samples for Extraction of BACTERIAL DNA

Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months.

Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome).

Irit Allon, MD, Phd

Irit Alon, MD, Phd

Oral squamous cell carcinoma (OSCC) is the most common malignant tumor of the head and neck, and its incidence has increased in recent years. Extensive surgery with neck dissection and chemo/radio/ targeted therapy is the current treatment for OSCC, and despite great progress in chemotherapy, radiotherapy, and targeted therapy in the last three decades, the prognosis of OSCC is still poor due to aggressive local invasion and metastasis, which lead to recurrence. Postoperative tumor recurrence confers a poor prognosis in OSCC and a poor quality of life. The 5-year survival rate is over 90% in OSCC patients without recurrence and 30% in patients with recurrence, with a median survival of 76.8 months in patients without recurrence and 42.5 months in patients with recurrence . Therefore, it is important to identify biomarkers that may predict the postoperative recurrence of OSCC. Also, some of the OSCC are preceded by precursor lesions. In the oral cavity the most common lesions recognized as potentially malignant are leukoplakia and erythroplakia, but it is also apparent that as many as 50% of OSCC arise from apparently clinically normal mucosa. The prognostic significance of an individual lesion is difficult to determine. At present therefore, the gold standard for the assessment of oral potentially malignant lesions is microscopic evaluation of haematoxylin and eosin stained sections for the presence of architectural and cytological changes, which are generally referred to as oral epithelial dysplasia (OED). The human microbiome is defined as the collective genomes of the microbes (composed of bacteria, bacteriophages, fungi, protozoa and viruses) that live inside and on the human body, and there are approximately 10 microbes and 100 microbial genes for each human cell and gene respectively. With the advent of next generation sequencing technology, the Human Microbiome Project delineated the composition of healthy microbial communities associated to different body sites in healthy individuals, including the oral cavity \[Human microbiome consortium\]. As opposed to a normal (healthy) microbiome, a disrupted microbiome or dysbiosis represents the lack of equilibrium, and is hypothetically related to disease. Interestingly, the healthy oral microbiome shows relative intraindividual stability over time, suggesting that differences in microbiome profiles may serve as useful tools for the identification of disease states. The working hypothesis is that in OSCC patients, the oral microbiome is altered in comparison to healthy individuals and certain microbial signatures are characteristic of healthy versus disease. In addition, in precursor conditions, i.e., oral epithelial dysplasia (OED), a partial alteration in the composition of the microbiome may predict the progression to malignancy.Also, during treatment, it could be that specific microbial signatures are associated with incomplete eradication, tendency to local recurrence or metastatic potential.Correlations to local recurrence (LR), distant metastases (DM) or disease free survival (DFS) adjusted to clinicopathologic correlations will be sought. In this study, buccal mucosa samples will be collected from patients with OSCC, OED and from healthy individuals , after signing for informed consent, according to Helsinki protocol. Routine pathologic diagnosis will be performed by expert Pathology physicians in our center. Data will be correlated to demographic and clinical data obtained from medical records. This will be carried out in line with institutional ethical guidelines.

The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw

Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome). The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (day 1). FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal. The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS. Samples will be kept at 4oC until frozen at -80oC. Each sample will be assigned a protocol serial number, de-identified from the subject.

1Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome). The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 3). FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal. The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS. Samples will be kept at 4oC until frozen at -80oC. Each sample will be assigned a protocol serial number, de-identified from the subject.

Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome). The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 6). FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal. The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS. Samples will be kept at 4oC until frozen at -80oC. Each sample will be assigned a protocol serial number, de-identified from the subject.

Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome). The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 9). FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal. The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS. Samples will be kept at 4oC until frozen at -80oC. Each sample will be assigned a protocol serial number, de-identified from the subject.

3. Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome). The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 12). FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal. The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS. Samples will be kept at 4oC until frozen at -80oC. Each sample will be assigned a protocol serial number, de-identified from the subject.

Barzilai Medical Center

DMD, PhD, Principal Investigator

Mouth and Tooth Diseases

Disease Progression

Mouth Neoplasms

Carcinoma in Situ

Oral Cancer

Lip and Oral Cavity Cancer

no intervention

Zhaojun Liu, PhD

Zhaojun Liu, Ph.D

Dajun Deng, M.D

Dajun Deng, MD

The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.

Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 hydroxymethylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.

Methods:265 patients with histologically confirmed mild or moderate OED were included in the present study. After the bisulfite modification and tet assistant bisulfite modification, MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and status in these patients. Building three follow-up queue by p16-methylated, p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. All P-values were two-sided. P\<0.05 was considered to test for statistical significance difference.

Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced；or frozen tissues;

Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation

The number of the participants of different groups and the followup information will be shared with other researchers after the end of the study.

Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.

Peking University

Beijing Municipal Administration of Hospitals

Digital colposcope will be used to detect the swede score of the lesion

Diagnostic accuracy of colposcopic examination; Swede scoring system will be used to evaluate the colposcopic examination. Then, the specificity (%) and the sensitivity (%) of colposcopic examination will be calculated using the cutoff value of 8 to segregate dysplastic from non-dysplastic lesions.

Digital colposcope

Sarah A Mohamed, Master

The aim of this work is to detect the diagnostic accuracy of the intra-oral application of colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and histopathological examination.

A- Roles and Responsibilities:

1. The Principle Supervisor: Dr. Mohsen Kazem (M.K.), Professor of Oral \&Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
2. The Assistant Supervisor: Dr. Heba Dahmoush (H.D.), Professor of Oral \& Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
3. The Principle Investigator: Sarah Ahmed Mohamed Mahmoud Badawy (S.B.), Assistant Lecturer of Oral \&Maxillofacial Pathology, Cairo University, will read and put a colposcopic score for each participant individually.
4. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
5. Evidence Based Committee, Faculty of Dentistry, Cairo University: Help in reporting study protocol following STARD guidelines.
6. Ethics Committee, Faculty of Dentistry, Cairo University: Protocol reviewer of the diagnostic accuracy study in order to protect the right, safety, dignity and well-being of the participants.

B- Index test: The principle investigator (S.B.) will perform the index test using Digital Electronic Colposcope (Kernel, KN-2200, China). Before taking up the patients for Colposcopic evaluation and giving them a score, the normal Colposcopic findings will be standardized based on the Colposcopic criteria. Colposcopic criteria includes aceto uptake, surface pattern and clarity of demarcation of the mucosal lesions, vascular pattern, lesion size as well as Iodine staining.

C- Reference test:The reference standard; to reach a definitive diagnosis in oral dysplastic lesions, will be a representative biopsy and histopathological examination. M.K. and H.D. will examine the taken biopsy histopathologically, determine the definitive diagnosis and write the diagnosis in the Assessor chart.

Inclusion criteria:

* Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
* Patients seeking for diagnosis of clinically suspected oral Carcinoma.

Exclusion criteria:

* Patients with secondary infection.
* Patients having other systemic diseases.
* Patients undergoing treatment for the lesions.

Colposcopy in Detection of Oral Epithelial Dysplasia

Diagnostic Accuracy Of Colposcopic Examination in Patients With Oral Dysplastic Lesion (Diagnostic Accuracy Study)

using digital colposcope (Kernel, KN-2200, China)

Cairo University

assistant lecturer, oral & maxillofacial pathology department, cairo university

Skin and Connective Tissue Diseases

Keratosis

Hyperplasia

Mouth Diseases

Leukoplakia

Erythroplasia

Stomatognathic Diseases

Erythroplakia

No dysplasia, mild, moderate, severe dysplasia, CIS

Assessment for risk of progression to oral cancer

STRATICYTE™ Test

Jody Filkowski, BSc, MSc, PhD

Jason TK Hwang, HBSc, MSc, PhD

Andrew G Sikora, MD, PhD

Simon W Young, DDS, MD, PhD

The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.

The study objectives are to:

1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.

FFPE specimens immunohistochemically stained with S100A7

Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™

Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy

Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk.

From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant.

The University of Texas Health Science Center, Houston

Loma Linda University

Minnesota Oral & Facial Surgery

University of Alabama at Birmingham

Proteocyte Diagnostics Inc.

patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.

patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.

Hongwei Liu, MD, PhD

Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. Biomarker is not available for detection of malignant potential of OED till now. p16 is an important tumor suppressor gene, which is inactivated frequently by methylation of CpG island in early stage of carcinogenesis. The present cohort study is to investigate whether p16 methylation is correlated with malignant transformation of OED.

* Background: Identification of malignant potential of oral epithelial dysplasia (OED) is virtually impossible on histopathological grounds alone. Inactivation of p16 gene by CpG methylation is an early frequent event during oral carcinogenesis. To investigate the predictive value of p16 methylation on malignant potential in OED, we carried out the prospective cohort study.
* Methods: 101 patients with histologically confirmed mild or moderate OED were included in the present study. Baseline information of p16 methylation status of the OED lesions from 93 cases was obtained by methylation-specific PCR. Progression of the OEDs lesions was examined in 78 cases histologically during the 45.8 months double-blind followup survey (78/93). The association between p16 methylation and progression of OED was analyzed with SPSS13.0 software. All P-values were two-sided.

Tissue specimen are collected from outpatients and inpatients with oral leukoplakia by biopsy or surgical resection, fixed in neutral buffered formalin, and embedded in paraffin. Genomic DNA is extracted from tissue sections.

Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia

A Cohort Study on Prediction of Malignant Transformation of Oral Epithelial Dysplasia by p16 Methylation

The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.

Professor and Department Director

All participants only got regular examinations during the followup period. No extra treatment was administrated.

p16-methylated

p16-unmethylated

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

China

Region of Enrollment

Department of Etiology

The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia

Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia

Overall Study

Infections

Behaviors and Mental Disorders

Fibrosis

Lichen Planus, Oral

Lichen Planus

Candidiasis

Oral Submucous Fibrosis

Leukoplakia, Oral

Lichenoid Eruptions

Exanthema

Skin Diseases

Skin Diseases, Papulosquamous

Pathological Conditions, Anatomical

Quality of Life

Chronic Graft Versus Host Disease

Oral Leukoplakia

INCLUSION CRITERIA

These include:

* Adults aged 18 or above at the time of the screening visit.
* Good command of English language both written and spoken \[this is necessary as questionnaires are in English and cannot be translated unless through a cross-cultural validation study\].
* Being able to consent.
* Diagnosed with OED as per current standard diagnostic criteria.
* No concurrent malignancy in the head and neck or elsewhere.

No intervention was/is planned for this study. The study is questionnaire-based (observational).

No intervention is planned for this study

Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (\<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED.

Project aims: To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED.

Timescale: 19 months.

Clinical significance: This questionnaire can be useful in clinical practice. It could help to meet the patient's information needs and plan educational interventions for those showing unmet needs.

Oral epithelial dysplasia (OED) is a disease associated with an increased risk of oral cancer between 6% and 36% compared to disease-free individuals. In the United Kingdom, oral cancer is among the 15 most common cancers, with approximately 6,000 new cases per year and these numbers are expected to rise in the few coming years.

Research showed the importance of patient education and the provision of information in shared-decision making and management of chronic and cancer-linked disease such as perhaps OED. However, patients may not be satisfied with the information provided by healthcare professionals, despite the extensive nature of the information provided. Having unmet informational needs may associate with higher anxiety levels which in turn could affect the patient's well-being and cooperation with the treatment provided.

Avoiding these undesirable health outcomes requires the delivery of tailored and patient-centred care that provides information based on what patients truly need and prefer. One increasingly common method to do so is to obtain this information by informational needs questionnaires. These questionnaires have been developed for other medical conditions including chronic diseases and some cancers, but none of these is known to be appropriate to use for OED specifically. Hence, a specific tool to determine the informational needs and preferences of patients with OED may help to achieve these objectives effectively. The data collected by this tool may help to acknowledge the impact of the illness on physical and psychological well-being. Furthermore, this data could be used to produce a source of OED information (such as a patient information leaflet) that reflects the IN of this patient population.

In the preliminary work for this study, the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q) was developed by adopting existing valid and reliable instruments that explore the information need of patients with potentially malignant disease elsewhere in the body, using experts input. The questions were then formulated and tested for content validity by clinicians (n=12) and patients (n=5), with unclear, irrelevant, redundant, and unacceptable items omitted. The final 35-item ODIN-Q includes two scales: (1) amount of information already received (too much, enough, not enough and none) and (2) degree of importance of the information (very, yes, not very, not at all).

Thus, the objectives of this study are to (1) test the newly developed ODIN-Q in a cohort of patients with OED; (2) to investigate the correlations between patients' informational needs and both of psychological variables (e.g. anxiety and depression) and quality of life; and (3) to develop and a Patient Information Leaflet (PIL) for OED based on patients' needs and preferences.

Oral Epithelial Dysplasia Informational Needs Questionnaire

Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire

To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED (Phase 1).

To investigate the correlation between psychological variables (e.g. anxiety and depression), quality of life (QoL) and information needs by analysis of the data collected by ODIN-Q, Krantz Health Opinion Survey, Hospital Anxiety and Depression Scale, Modified Dental Anxiety Scale and the Oral Health Impact Profile-14 (phase 1).

To develop and assess the satisfaction with a patient information leaflet \[PIL\] about OED (phase 2).

University College London Hospitals

University College, London

48 patients with mild or moderate oral epithelial dysplasia containing methylated p16.

104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16.

The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.

Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.

Methods:180 patients with histologically confirmed mild or moderate OED were included in the present study. The investigators using p16 methylation diagnostic reagents to analysis of the p16 methylation status in these patients. Building two follow-up queue by p16-methylated and p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were two-sided. P\<0.05 was considered to test for statistical significance difference.

Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced and hematoxylin-eosin (HE) staining.

Early Diagnosis of Oral Cancer by Detecting p16 Methylation

A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation

152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides.

Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.

Peking University School and Hospital of Stomatology

No evidence of dysplasia

Mild dysplasia

Moderate dysplasia

Severe dysplasia

Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer

Standard of Care Histopathology

STRATICYTE Assessment

Jason Hwang, PhD

Mark Darling, MSc, MChD

Tim McGaw, DDS, MSc, MD

The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.

Background: The standard of care for potentially premalignant oral epithelial lesion (PPOEL) risk assessment for progression to cancer is dysplasia grading by histopathology. With significant overlap between dysplasia grades and high inter- and intra-observer variations, dysplasia grading alone has been shown to be inadequate as a prognostic tool. To investigate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in the early diagnosis of invasive oral cancer, a prospective multi-center observational study was designed with specimens obtained from community-based practices.

Methods: Patients that qualify to enroll in the study will be assessed for both standard of care histopathological assessment for dysplasia grade and STRATICYTE risk assessment, and followed for up to 60 months (from initial biopsy) to determine the outcome of their oral lesion(s).

Formalin-fixed paraffin-embedded tissue sections stained with H\&E and S100A7

Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment

A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE

Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw	NCT03418454	Oral Squamous C... Medication Rela... Oral Epithelial...	Buccal mucosa s...	20 Years - 90 Years	Barzilai Medical Center
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw	NCT03418454	Oral Squamous C... Medication Rela... Oral Epithelial...	Buccal mucosa s...	20 Years - 90 Years	Barzilai Medical Center
Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation	NCT02967120	Oral Epithelial...	no intervention	25 Years -	Beijing Municipal Administration of Hospitals
Colposcopy in Detection of Oral Epithelial Dysplasia	NCT03075098	Intraepithelial...	Digital colposc...	-	Cairo University
Colposcopy in Detection of Oral Epithelial Dysplasia	NCT03075098	Intraepithelial...	Digital colposc...	-	Cairo University
Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™	NCT05853783	Mouth Diseases	STRATICYTE™ Tes...	18 Years -	Proteocyte Diagnostics Inc.
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia	NCT00835341	Oral Epithelial...		-	Peking University
Oral Epithelial Dysplasia Informational Needs Questionnaire	NCT04153266	Oral Epithelial... Precancerous Co... Precancerous Le... Oral Lichen Pla... Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Erythropla... Chronic Hyperpl... Oral Submucous ... Oral Submucosal... Oral Disease Dental Diseases Dysplasia Information See... Patient Prefere... Information Nee... Health Behavior Quality of Life Preference, Pat... Patient Satisfa... Patient Engagem... Patient Partici...	No intervention...	18 Years -	University College, London
Early Diagnosis of Oral Cancer by Detecting p16 Methylation	NCT01695018	Moderate Epithe... Mild Epithelial...		25 Years - 78 Years	Peking University
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment	NCT04622462	Oral Neoplasm	Standard of Car... STRATICYTE Asse...	15 Years - 90 Years	Proteocyte Diagnostics Inc.
Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia	NCT00835341	Oral Epithelial...		-	Peking University

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