Clinical Trial Finder
Using MASL to Combat Oral Cancer
Study Purpose
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).
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
1. Males and females of at least 18 years of age who are able to give consent. 2. Smokers and non-smokers. 3. 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. 4. 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. 5. patients will be considered for inclusion at any stage of disease progression. 6. Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment. 7. Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1. 8. Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine. 9. Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions.Exclusion Criteria:
1. Patients with cognitive impairments and cannot consent for themselves. 2. Patients with language/hearing impairments. 3. Use of a topical steroid product within the last 2 weeks. 4. Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice. 5. Patients who are breastfeeding. 6. Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: MASL treated
Patients treated with lozenge containing MASL
Placebo Comparator: Placebo treated
Patients treated with lozenge without MASL
Interventions
Drug: - MASL
Patients treated with MASL lozenge
Other: - Placebo
Patients treated with placebo lozenge
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
New Jersey Medical School
Newark, New Jersey, 07103
Site Contact
Mahnaz Fatazadeh, DMD, MSD
[email protected]
973-972-1956
Status
Recruiting
Address
Rutgers School for Dental Medicine
Newark, New Jersey, 07103
Site Contact
Mahnaz Fatahzadeh, DMD, MSD
[email protected]
973-972-1956
Status
Not yet recruiting
Address
University Hospital
Newark, New Jersey, 07103
Site Contact
Mahnaz Fatazadeh, DMD, MSD
[email protected]
973-971-1956
Status
Not yet recruiting
Address
Rowan University
Stratford, New Jersey, 08084
Site Contact
GARY GOLDBERG, PhD
[email protected]
856-566-6718
Privacy Overview