Recruiting

Observational Study

Sponsor:

New York University

Code:

NCT07095608

Conditions

Oral Cancer

Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pressure and stretch sensitivity testing

Study Details

Brief summary:

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.

Conditions

Oral Cancer

Squamous Cell Carcinoma

Study ID

NCT07095608

Start date

Sep 1, 2025

Status verified date

Nov, 2025

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Oral Cancer Subjects

Oral cancer patients will be tested for pressure and stretch sensitivity. Pressure sensitivity will be evaluated with a digital pressure algometer by applying the probe tip to the site of cancer in oral cancer patients.

Stretch sensitivity will be evaluated with visual analog scale recording of pain scores associated with tongue range of motions in oral cancer patients.

active comparator: Healthy Subjects

Healthy subjects will be tested for pressure and stretch sensitivity. Pressure sensitivity will be evaluated with a digital pressure algometer by applying the probe tip to the tongues of healthy subjects.

Stretch sensitivity will be evaluated with visual analog scale recording of pain scores associated with tongue range of motions in healthy subjects.

Interventions

Pressure and stretch sensitivity testing

We will measure pressure sensitivity by applying gradual pressure (50 kPa/s) at the site of testing using a digital pressure algometer. In healthy subjects, we will perform these measurements on the lateral tongue on the left and the right side. In cancer patients, we will first test on the unaffected contralateral matched site and then at the site of the cancer. We will define pressure sensitivity as the mean of three threshold measurements.

For measuring stretch sensitivity, we will use a visual analog scale (VAS) recording of pain scores associated with tongue stretching. Participants will be asked to perform tongue range of motions (ROM): protrusion, elevation, right and left lateralization, and rate sensitivity score on the VAS scale after holding the tongue in position for five seconds. We will define stretch sensitivity as the sum of VAS scores for protrusion, elevation, right and left lateralization.

Primary outcome measure

  • Pressure sensitivity [ Time Frame: Baseline ]
  • Stretch sensitivity [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Yatendra Mulpuri, PhD

424-230-4222ym2891@nyu.edu

Mariana Bucovsky, MHA

212-998-9389mb10357@nyu.edu

Locations

NYU College of Dentistry

Recruiting

New York, New York, United States, 10010

Contacts

Yatendra Mulpuri, PhD

424-230-4222ym2891@nyu.edu

Mariana Bucovsky, MHA

212-998-9389mb10357@nyu.edu

Principal Investigator:

Brian L Schmidt, DDS

More Information

Sponsor

New York University

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2025-11-21.