Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
Recruiting
N/AInterventional Study
Oral CancerSquamous Cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
80 (estimated)
Sponsor
New York University · Other
Who this trial is looking for
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This is a prospective study involving human participants. Pressure and stretch sensitivity measures between oral cancer patients and healthy subjects will be compared. Pain stimulation will be conducted on the site of the cancer in 40 oral cancer patients, and on the tongue in 40 healthy volunteers, using pressure and stretch sensitivity tests.
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Eligibility Criteria
Inclusion Criteria:
For healthy subjects to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or femal…
Inclusion Criteria:
For healthy subjects to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, at least 18 years of age
* In good general health as evidenced by medical history
For oral cancer patients to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, at least 18 years of age
* Biopsy-proven squamous cell carcinoma (SCC) of the oral cavity that requires surgical resection
* Lesion is at least 1 cm in greatest surface dimension
Exclusion Criteria:
* Healthy subjects who meet any of the following criteria will be excluded from participation in this study:
* Clinically and/or histologically proven oral pre-cancer, oral cancer
* Pregnancy or lactation (Female subjects of child-bearing potential will have a rapid urine pregnancy test)
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Oral cancer patients who meet any of the following criteria will be excluded from participation in this study:
* History of prior surgical, chemotherapeutic, or radiation treatment for head and neck cancer
* Pregnancy or lactation
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
For participants with impaired kidney function (chronic kidney/renal disease) who wish to participate in the proposed research study, consultation with their primary care provider will be done prior to enrollment to determine safety
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