Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Precancerous Conditions

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

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

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Keratosis

Hyperplasia

Disease Progression

Leukoplakia

Erythroplasia

Mouth Diseases

Stomatognathic Diseases

Erythroplakia

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

Assessment for risk of progression to oral cancer

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
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
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.

Spots Global Cancer Trial Database for opmd

Every month we try and update this database with for opmd 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 opmd

Every month we try and update this database with for opmd 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 opmd 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.