How TRPV4 in Schwann cells contributes to oral cancer pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective protocol will enroll 40 adults with biopsy-proven oral squamous cell carcinoma and 40 healthy adult volunteers. Investigators will perform standardized pressure and stretch sensitivity tests at the tumor site in patients and on the tongue in controls, recording pain thresholds and intensity. When available, surgical tissue or isolated Schwann cells will be analyzed for TRPV4 expression to correlate molecular findings with sensory measures. The approach aims to link mechanosensitivity in patients to TRPV4 activity in Schwann cells as a possible mechanism driving oral cancer pain.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU College of Dentistry
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Brian L Schmidt, DDS — NYU College of Dentistry
• Study coordinator: Yatendra Mulpuri, PhD
• Email: ym2891@nyu.edu
• Phone: 424-230-4222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.