Neoplasms

All Conditions

Mouth and Tooth Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Lichen Planus, Oral

Lichen Planus

Mouth Neoplasms

Leukoplakia

Leukoplakia, Oral

Lichenoid Eruptions

Exanthema

Skin Diseases

Skin Diseases, Papulosquamous

Mouth Diseases

Stomatognathic Diseases

Precancerous Conditions

Pathological Conditions, Anatomical

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Oral Leukoplakia

Manuel Weber, MD, DMD

Falk Wehrhan, MD, DMD

Jutta Ries, PhD

Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Early detection and prevention of OSCC is thought to have the highest potential to reduce morbidity and mortality. In prevention, the main focus is on precancerous lesions, especially oral leukoplakia (OLP), as up to 67% of OSCC arise on the basis of OLP. The determination of the transformation risk of OLP by histological determination of the degree of dysplasia is unreliable.

A promising marker for the timely development of a OSCC is the detection of antigens of the MAGE-A gene family. The special feature of MAGE-A is that they can be detected in 93% of all OSCC and in approx. 85% of OLP that transform to OSCC. The detection of MAGE-A could also indicate changes in the immunological environment that occur prior to malignant OLP transformation and could be used for immunotherapies.

Aim of this study is to investigate MAGE-A as a predictive marker for the malignant transformation of OLP in the setting of a prospective, multicenter study and to establish it as a diagnostic parameter in addition to classical histology. In addition, the association of MAGE-A expression with the occurrence of immunological changes in OLP will be investigated in order to evaluate the possibility of minimally invasive immunotherapy of OLP.

The study is intended to include 500 biopsies of non-selected patients with OLP from university institutions and private practices. The follow-up should be at least 3 years, whereby it is examined whether an OSCC on the basis of the original OLP developed. After three years, an interim evaluation of the results with statistical evaluation will be carried out. In order to ensure that the course of the disease is monitored for at least three years for all OLPs, an extension of the monitoring period to 5 years is planned.

The study could establish a routine diagnostic parameter to supplement the histo-morphological diagnosis of OLP and evaluate the possibility of immunotherapy of OLP.

Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Despite the introduction of microsurgical reconstruction options and advances in multimodal tumor therapy, the prognosis has not improved significantly in the last 30 years.

The most important aspect for increasing survival rate is seen in the early detection of OSCC and its precursor lesions. Up to 67 % of OSCC develop on the basis of oral leukoplakia (OLP), which frequently occur prior to the diagnosis of carcinoma. OLP treatment depends on the risk of malignant transformation. Therapeutic approaches range from simple observation to complete surgical excision of OLP. The scientific evidence regarding the handling of OLP is low. Current literature outlines missing evidence in therapeutic management of OLP. The early identification of OLP with a high risk of malignant degeneration is a relevant clinical question, since approx. 2% of OLPs transform malignantly each year. In lesions with dysplasia this rate increases to about 17%.

Gold standard for determining the risk of malignant transformation of OLP is the histologic determination of the degree of dysplasia. As the histological degree of dysplasia increases, so does the risk of developing PECM on the basis of OLP. The decision for a surgical or a conservative therapy currently depends on the degree of dysplasia of the OLP. The histopathological assessment of the degree of dysplasia is subjective and depends on the experience of the pathologist making the assessment. However, the major disadvantage in assessing the malignant transformation potential with this method is that many precursor lesions do not follow the histopathologically determined degree of dysplasia. Thus, 0-3% of hyperplasias (D0) and up to 30% of mild dysplasias (D1) transform to OSCC. D0 OLP are lesions, which are usually only observed according to current therapy recommendations. Thus, an assessment of the dignity of OLP and a long-term prediction of the risk for the development of OSCC are not reliable. OLP with a histopathologically low malignancy potential but a cell-biologically probable malignant transformation must be identified in order to prevent undertreatment of these patients.

The aim of this explorative study is to investigate whether the malignant transformation of OLP can be reliably predicted using immunohistochemical and molecular biological methods. A significant association of the expression of MAGE-A expression with the malignant transformation of OLP to OSCC has already been demonstrated in retrospective studies. It is now necessary to further develop these available test procedures and evaluate them in a prospective study in order to transfer them into clinical routine. Sensitivity and specificity of the investigated markers will be investigated in a prospective, multicenter setting. A non-selected group of patients will be examined. The aim is to establish a test procedure that can be used cost-effectively. The MAGE-A expression should serve as an indicator and for the application of new, innovative therapy concepts such as the immunotherapy of OLP.

The following questions will be answered:

i) Do OLP with malignant transformation show an increased MAGE-A expression in a time interval of 3 years (follow-up up to 5 years)? ii) How high is the sensitivity and specificity of MAGE-A expression as a predictive diagnostic test? Is immunohistochemical or molecular biological (RT-PCR) detection of MAGE-A better suited as a diagnostic test? iii) Can MAGE-A be used successfully as a diagnostic test in practice? iv) Is there an association between MAGE-A expression and immunological changes preceding malignant transformation (macrophage polarization, T cell infiltration, checkpoint expression, TLR expression)? v) Are the immunological changes in OLP potentially amenable to immunomodulatory therapy?

Short summary of the study protocol:

After the patient has been informed and included in the study, the first step is the photo documentation and then the incision biopsy of the OLP. The treating physician is free to choose whether to take a sample from one or more sites of the lesion. This procedure complies with the standard diagnostic guidelines and is not a study-specific measure. Thus, there is no deviation from the clinical routine for the study and no invasive measure required by the study. The sample taken is then divided. The total amount of tissue taken corresponds to the amount taken in the routine outside the study. One part of the sample is conventionally fixed in formalin. The second part (max. 5x5x2mm) is preserved in RNA later for later PCR analysis. Both samples will be sent to the study center in Erlangen. There the histological evaluation of the tissue takes place in the Pathological Institute of the University Hospital Erlangen within routine diagnostics. The result is communicated to the treating physician and the study centre. The immunohistochemical and molecular biological analyses are carried out in the laboratories of the Oral and Maxillofacial Surgery Erlangen. The results of the analyses are not communicated to the attending physician (blinding). A therapy decision is only made on the basis of clinical and classical histological parameters (degree of dysplasia). D0 and D1 lesions are monitored. D2 and D3 lesions are treated surgically or with laser coagulation depending on the decision of the treating physician and patient. This corresponds to the current clinical standard. If the patient rejects the treatment of the lesion and wishes to continue observing its progress, he remains included in the study. The follow-up time during the study period is 3 years (evaluations also after 2 years). After completion of the study a further follow-up of 2 years is planned in order to achieve a total follow-up of 5 years.

paraffin specimens and RNAlater specimens

Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore

Prospective Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore

Association of OLP malignant transformation with a MAGE-A based immunoscore. Into this score, the following immunohistochemical and molecular biological parameters determined in biopsies will be integrated:

* MAGE-A expression
* Macrophage infiltration and polarization (CD68, CD163)
* T cell infiltration (CD3, CD8)
* Altered expression of immune checkpoints and TLR receptors (PD-L1, PD-L2, TLR7) These parameters will be aggregated to an immunoscore

Frequency of malignant transformation of OLP (determination of the incidence of OSCC in OLP cases)

Dependence of malignant transformation on histologically determined degree of dysplasia (D0-D3)

University of Erlangen-Nürnberg Medical School

Dr. med. Dr. med. dent. Manuel Weber, MD, DMD, Principal Investigator

Tongue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Tongue Diseases

Flavonoid

All Drugs and Chemicals

Luteolin

nano-particles derived from a natural extract luteolin

luteolin

nano-luteolin

Safaa M. Baz, Masters

Safa F. Abd El-Ghani, PhD

Ahmed Elkhadem, PhD

In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.

This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell viability.

Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line

Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study

Cairo University

Assistant Lecturer, Oral and Maxillofacial Pathology, BUE

Squamous Cell Carcinoma of Head and Neck

OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.

OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.

OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:

* Dysplasia
* Hyperplasia
* Leukoplakia
* Erythroplasia
* Lichenoid lesions
* Actinic Keratosis
* Lichenoid reaction
* Aphthous ulcer/ Canker Sores
* Gingival enlargement (side effect)
* Lichen planus
* Keratosis
* Inflammatory reaction
* Cheek bites

Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities.

The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.

OralViome Cancer Testing System

Mory Mehrtash, MSc

Momchilo Vuyisich, PhD

Gavin Hougham, PhD

Bruno Villazhinay, MPH

Cristina Julian, PhD

To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.

This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.

A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.

Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

The test results will be compared against the definitive diagnosis by the physician.

New York Medical College

Viome

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

A clinical-biological cohort of 30 patients with epidermoid carcinomas of the oral cavity.

Blood sample and cytobrush sample at inclusion and before anti-cancer treatment.

Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients

Cytobrush sample

Blood sampling (6 mL), taken from a routine biological exam

Blood sampling

Philippe Zrounba, M.D.

Pierre Martinez, Ph.D.

The goal of this project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC).

Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality.

Despite recent advances in diagnosis, treatment and monitoring, the overall 5-year survival rate of patients with epidermoid carcinomas of upper aerodigestive tract has not improved significantly and remains around 40-50 % for all combined locations. These pejorative survival rates, as well as the increase in the incidence of these cancers, have not changed much over the past 30 years. This situation can be attributed in part to a diagnosis too late. Indeed, only 1/3 of patients with high-risk squamous cell carcinoma of the head and neck are diagnosed at an early stage. This issue of early diagnosis is mainly due to the lack of suitable screening and diagnostic biomarkers. Beyond diagnosis, the identification of biomarkers is also a prognostic and predictive interest since they could predict the course of the disease as well as the response to treatment.

"Drivers" mutations, with oncogenic potential, can be present from the very early stages of epidermoid carcinomas of upper aerodigestive tract and therefore constitute potential biomarkers. However, recent studies have demonstrated the presence of driver mutations in different types of oral cavity's healthy tissue, some being even associated with a protective effect against tumor initiation. In order to improve prevention and early diagnosis of OSCC, it is important to better understand the evolutionary dynamics of somatic mutations in the oral mucosa, which is still poorly characterized.

A clinical-biological cohort of patients with epidermoid carcinomas of the oral cavity.

Blood sample and cytobrush sample at inclusion and before anti-cancer treatment.

Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)

Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC)

Selective advantage of the 62 driver genes already identified

Selective advantage of non-driver OSCC genes

Identified mutations described by type and number

Correlation between tobacco consumption and total number of somatic mutations detected

Correlation between alcohol consumption and total number of somatic mutations

Centre Leon Berard

Tongue Cancer

T1 T2 and T3 OSCC tumor, patients who have a recent evaluation cervico thoracic scanner in their medical files.

We will analyse the pre operative scannographic and MRI (if available) images, and the post operative pathological analyses.

The scanners will be reviewed by 2 well trained clinicians (one head and neck radiologist and one head and neck surgeon).

Then we will analyse the correlation between the radiological and the pathological analysis.

Radiologic and pathological review.

Leonard MEGUERDITCHIAN, MD

The aim of the study is to assess the good correlation and prediction of the DOI for the post-operative pathological results and prognosis.

Radio/Pathological Evaluation of Tongue Cancer Infiltration

An Evaluation of the Radio/Pathological Correlation of Depth Of Invasion for Oral Squamous Cell Carcinoma, a Retrospective Study in a University Hospital in Lyon

With a Bland Altman analysis we will assess the good correlation between the pre and post operatory mesures of the depth of invasion in the oral squamous cell carcioma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore	NCT03975322	Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Lichen Pla...		18 Years - 80 Years	University of Erlangen-Nürnberg Medical School
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line	NCT03288298	Tongue Neoplasm... Carcinoma	luteolin nano-luteolin	-	Cairo University
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line	NCT03288298	Tongue Neoplasm... Carcinoma	luteolin nano-luteolin	-	Cairo University
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System	NCT05451303	Oral Squamous C... Oropharynx Squa... Premalignant Le...	OralViome Cance...	18 Years -	Viome
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System	NCT05451303	Oral Squamous C... Oropharynx Squa... Premalignant Le...	OralViome Cance...	18 Years -	Viome
Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)	NCT06425146	Oral Squamous C...	Cytobrush sampl... Blood sampling	18 Years -	Centre Leon Berard
Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore	NCT03975322	Oral Leukoplaki... Oral Leukoplaki... Oral Leukoplaki... Oral Lichen Pla...		18 Years - 80 Years	University of Erlangen-Nürnberg Medical School
Radio/Pathological Evaluation of Tongue Cancer Infiltration	NCT04821128	Oral Squamous Cell Carcinoma	Radiologic and ...	-	Hospices Civils de Lyon

Spots Global Cancer Trial Database for oscc

Every month we try and update this database with for oscc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oscc

Every month we try and update this database with for oscc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oscc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.