Using MASL to Combat Oral Cancer

Study Overview
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Brief Summary
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This project will evaluate the expression of a receptor called podoplanin (PDPN) in cells from oral cancers and precancerous lesions. We will also determine how sensitive oral cancer cells are to a potential drug called Maackia amurensis seed lectin (MASL).

Official Title
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Using Maackia Amurensis Seed Lectin to Target the Podoplanin Receptor as a Functionally Relevant Biomarker to Inhibit the Growth of Oral Squamous Cell Carcinoma and Precancerous Lesions

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Drug: MASL
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females of at least 18 years of age who are able to give consent. Smokers and non-smokers. Persons with white or red spots and/or lesions suspected or found to be oral cancer or precancer on the inner surface of the mouth. Oral lesions will be classified as OSCC or leukoplakia including, proliferative verrucous leukoplakia, conventional erythroplakia, suspect oral papillomas, or oral lichen planus. Only patients with such histologically confirmed diagnoses will be considered for inclusion. patients will be considered for inclusion at any stage of disease progression. Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment. Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine. Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions. Exclusion Criteria: Patients with cognitive impairments and cannot consent for themselves. Patients with language/hearing impairments. Use of a topical steroid product within the last 2 weeks. Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice. Patients who are breastfeeding. Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MASL treated<br>Patients treated with lozenge containing MASL | Drug: MASL<br>* Patients treated with MASL lozenge<br>* Other names: Maackia amurensis seed lectin;|
| Placebo Comparator: Placebo treated<br>Patients treated with lozenge without MASL | Other: Placebo<br>* Patients treated with placebo lozenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-treatment OSCC morphology and PDPN expression | Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We will select patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. | 1 day to 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment OSCC morphology and PDPN expression | Evaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry. | 1 day to 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maackia amurensis, podoplanin, pdpn, lectin, oral squamous cell carcinoma