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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Pre-treatment OSCC Morphology and PDPN Expression
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
MASL treated
Patients treated with lozenge containing MASL
干预措施: MASL (Drug)
Placebo treated
Patients treated with lozenge without MASL
干预措施: Placebo (Other)
结局指标
主要结局
Pre-treatment OSCC Morphology and PDPN Expression
时间窗: 1 day.
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 selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression.
次要结局
- Post-treatment OSCC Morphology and PDPN Expression(1 day)