Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

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

oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy

cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

saliva collection prior to clinically driven oral biopsy

Michael Shaw, PhD

Harvey Zalesin, DDS

Paul Hoff, MD

Marc Surkin, MD

Jack L Martin, MD

The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.

Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.

Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer

Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma

Based on comparison of cancer and controls

Based on combined sensitivity and specificity

PeriRx

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Keratosis, Actinic

Keratosis

Lichen Planus, Oral

Lichen Planus

Leukoplakia

Leukoplakia, Oral

Skin Diseases

Precancerous Conditions

Lichenoid Eruptions

Exanthema

Skin Diseases, Papulosquamous

Mouth Diseases

Stomatognathic Diseases

Pathological Conditions, Anatomical

Oral Leukoplakia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Vasodilator Agents

Respiratory System Agents

Nitrous Oxide

Nitric Oxide

salivary biomarker

weam Elbattawy, Phd

investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.

Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6).

In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6).

Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions

Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

all the data will shared once the work is published

The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.

The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.

Beni-Suef University

principle investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer	NCT01587573	Oral Squamous C...	saliva collecti...	18 Years -	PeriRx
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions	NCT04267419	Oral Lichen Pla... Oral Cancer Leukoplakia Oral Keratoses	salivary biomar...	18 Years - 70 Years	Beni-Suef University
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions	NCT04267419	Oral Lichen Pla... Oral Cancer Leukoplakia Oral Keratoses	salivary biomar...	18 Years - 70 Years	Beni-Suef University

Spots Global Cancer Trial Database for salivary biomarkers