Oral CancerNCT07095608
Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
A study testing Pressure and stretch sensitivity testing in people with Oral Cancer and Squamous Cell Carcinoma, run by New York University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Squamous Cell Carcinoma
- What is being tested?
- Pressure and stretch sensitivity testing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU College of Dentistry
New York, New York, 10010
Yatendra Mulpuri, PhD, 424-230-4222, ym2891@nyu.edu
Mariana Bucovsky, MHA, 212-998-9389, mb10357@nyu.edu
About this study
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.
Read the detailed description
Oral cancer, particularly squamous cell carcinoma (SCC), represents nearly 90% of all head and neck cancers. Most patients with oral cancer experience functional pain caused by pressure at the cancer site, along with discomfort from stretching during activities like talking, drinking, and swallowing. However, the intensity and nature of this pain can vary significantly among individual patients. Currently, there are no effective treatments available to relieve pain associated with oral cancer.
The current hypothesis regarding the cause of oral cancer pain suggests that oral cancers release pain mediators that sensitize and activate receptors on sensory nerves associated with cancer. Mechanosensitive ion channels, such as TRPV4, PIEZO1, and PIEZO2, are activated by pressure and stretch, and have been implicated in pathological pain. Preclinical studies show that mice lacking TRPV4 have impaired pressure sensation, and inhibiting TRPV4 in models of oral cancer reduces mechanical pain. TRPV4 is expressed in various cell types, including epithelial cells, fibroblasts, neurons, and Schwann cells, which are the glial cells that ensheathe the axons of sensory neurons. Cancer cells and Schwann cells interact reciprocally, promoting cancer growth and pain. Preliminary data indicate that Schwann cells isolated from the trigeminal nerve fibers innervating the cancers of oral cancer patients express functional TRPV4. In human Schwann cells, the activation of TRPV4 mediates mechanosensitivity. A TRPV4 inhibitor currently in clinical trials has been well-tolerated by patients and has demonstrated a good safety profile. A better understanding of TRPV4's role in oral cancer pain holds significant promise for the development of TRPV4 antagonists as new analgesics for alleviating pain in oral cancer patients.
There is a lack of published data regarding the effects of pressure and stretch on pain phenotypes in patients with oral cancers. This gap significantly hinders our understanding of the mechanisms underlying oral cancer pain. By quantitatively assessing the pressure and stretch sensitivities experienced by these patients, the investigators can gain valuable insights into the origins of their pain. In this proposal, the investigators hypothesize that the quality of pain experienced by oral cancer patients is influenced by the activation levels of mechanosensitive ion channels at the site of the cancer. The investigators will conduct sensitivity tests for pressure and stretch on oral cancer patients and compare the patients' sensitivities with those of healthy subjects. Furthermore, the investigators will evaluate the correlation between pressure and stretch sensitivity scores in oral cancer patients.
The investigators propose that the degree of pressure and stretch sensitivities experienced by oral cancer patients is quantifiable and depends on the functional expression of TRPV4 on Schwann cells.
- Conditions
- Oral Cancer, Squamous Cell Carcinoma
- Being tested
- Pressure and stretch sensitivity testing
- Medical subject headings
- Mouth Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure and stretch sensitivity testingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer Subjects | Experimental | 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. Receives: Behavioral: Pressure and stretch sensitivity testing |
| Healthy Subjects | Active comparator | 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. Receives: Behavioral: Pressure and stretch sensitivity testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure sensitivity
Pressure pain thresholds will be measured in kilopascals with a digital pressure algometer. The average of three measurements will be used to determine each threshold. Lower thresholds signify higher pain levels.
Measured: Baseline
Stretch sensitivity
Stretch sensitivity will be evaluated by assessing pain or discomfort associated with tongue range of motions (tongue protrusion, tongue elevation, right lateralization and left lateralization).To measure stretch sensitivity, visual analog scale (VAS) scores for participants' pain associated with tongue stretching will be recorded. Participants will perform tongue range of motions (ROM): protrusion, elevation, and right and left lateralization, and they will rate their sensitivity on the VAS scale after holding each position for five seconds. Subjects will also rate the quality of their pain. Stretch sensitivity will be defined as the sum of VAS scores for protrusion, elevation, and right and left lateralization. The VAS goes from 0-100, 0 representing no pain and 100 representing the most intense pain imaginable.
Measured: Baseline
Secondary outcomes (1)
To determine whether patients with lower pressure pain thresholds report higher pain scores on the visual analog scale after tongue stretching.
Pressure pain thresholds will be measured in kilopascals with a digital pressure algometer. The average of three measurements will be used to determine each threshold. Lower thresholds signify higher pain levels.
The tongue stretch questionnaire records the total VAS pain scores for lingual range of motion. Higher scores indicate more pain.
The dependent variables of the pressure and stretch tests will be evaluated for a linear relationship.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Brian L Schmidt, DDS, Principal investigator, NYU College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095608
- Sponsor's protocol ID
- 25-00531
- Other IDs
- 1K23DE034496-01
- Status last verified
- Nov 2025
- First submitted
- 11 Jul 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gormley M, Creaney G, Schache A, Ingarfield K, Conway DI. Reviewing the epidemiology of head and neck cancer: definitions, trends and risk factors. Br Dent J. 2022 Nov;233(9):780-786. doi: 10.1038/s41415-022-5166-x. Epub 2022 Nov 11.
PubMed 36369568Viet CT, Schmidt BL. Biologic mechanisms of oral cancer pain and implications for clinical therapy. J Dent Res. 2012 May;91(5):447-53. doi: 10.1177/0022034511424156. Epub 2011 Oct 4.
PubMed 21972258Szczot M, Liljencrantz J, Ghitani N, Barik A, Lam R, Thompson JH, Bharucha-Goebel D, Saade D, Necaise A, Donkervoort S, Foley AR, Gordon T, Case L, Bushnell MC, Bonnemann CG, Chesler AT. PIEZO2 mediates injury-induced tactile pain in mice and humans. Sci Transl Med. 2018 Oct 10;10(462):eaat9892. doi: 10.1126/scitranslmed.aat9892.
PubMed 30305456Nilius B, Voets T. The puzzle of TRPV4 channelopathies. EMBO Rep. 2013 Feb;14(2):152-63. doi: 10.1038/embor.2012.219. Epub 2013 Jan 11.
PubMed 23306656Mikesell AR, Isaeva E, Schulte ML, Menzel AD, Sriram A, Prahl MM, Shin SM, Sadler KE, Yu H, Stucky CL. Increased keratinocyte activity and PIEZO1 signaling contribute to paclitaxel-induced mechanical hypersensitivity. Sci Transl Med. 2024 Dec 11;16(777):eadn5629. doi: 10.1126/scitranslmed.adn5629. Epub 2024 Dec 11.
PubMed 39661703Suzuki M, Mizuno A, Kodaira K, Imai M. Impaired pressure sensation in mice lacking TRPV4. J Biol Chem. 2003 Jun 20;278(25):22664-8. doi: 10.1074/jbc.M302561200. Epub 2003 Apr 13.
PubMed 12692122Mulpuri Y, Tu NH, Inoue K, Harden G, Nicholson SJ, Seenauth A, Huang Y, Escobar KG, Moayedi Y, Bunnett NW, Albertson DG, Schmidt BL. TRPV4 activation in Schwann cells mediates mechanically induced pain of oral cancer. Front Pain Res (Lausanne). 2025 Mar 12;6:1532885. doi: 10.3389/fpain.2025.1532885. eCollection 2025.
PubMed 40144515Salvo E, Saraithong P, Curtin JG, Janal MN, Ye Y. Reciprocal interactions between cancer and Schwann cells contribute to oral cancer progression and pain. Heliyon. 2019 Feb 15;5(2):e01223. doi: 10.1016/j.heliyon.2019.e01223. eCollection 2019 Feb.
PubMed 30815600Goyal N, Skrdla P, Schroyer R, Kumar S, Fernando D, Oughton A, Norton N, Sprecher DL, Cheriyan J. Clinical Pharmacokinetics, Safety, and Tolerability of a Novel, First-in-Class TRPV4 Ion Channel Inhibitor, GSK2798745, in Healthy and Heart Failure Subjects. Am J Cardiovasc Drugs. 2019 Jun;19(3):335-342. doi: 10.1007/s40256-018-00320-6.
PubMed 30637626
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain
- ClinicalTrials.gov ID
- NCT07095608
- Acronym / sponsor ID
- 25-00531
- Conditions
- Oral Cancer, Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oral cancer, particularly squamous cell carcinoma (SCC), represents nearly 90% of all head and neck cancers. Most patients with oral cancer experience functional pain caused by pressure at the cancer site, along with discomfort from stretching during activities like talking, drinking, and swallowing. However, the intensity and nature of this pain can vary significantly among individual patients. Currently, there are no effective treatments available to relieve pain associated with oral cancer.
The current hypothesis regarding the cause of oral cancer pain suggests that oral cancers release pain mediators that sensitize and activate receptors on sensory nerves associated with cancer. Mechanosensitive ion channels, such as TRPV4, PIEZO1, and PIEZO2, are activated by pressure and stretch, and have been implicated in pathological pain. Preclinical studies show that mice lacking TRPV4 have impaired pressure sensation, and inhibiting TRPV4 in models of oral cancer reduces mechanical pain. TRPV4 is expressed in various cell types, including epithelial cells, fibroblasts, neurons, and Schwann cells, which are the glial cells that ensheathe the axons of sensory neurons. Cancer cells and Schwann cells interact reciprocally, promoting cancer growth and pain. Preliminary data indicate that Schwann cells isolated from the trigeminal nerve fibers innervating the cancers of oral cancer patients express functional TRPV4. In human Schwann cells, the activation of TRPV4 mediates mechanosensitivity. A TRPV4 inhibitor currently in clinical trials has been well-tolerated by patients and has demonstrated a good safety profile. A better understanding of TRPV4's role in oral cancer pain holds significant promise for the development of TRPV4 antagonists as new analgesics for alleviating pain in oral cancer patients.
There is a lack of published data regarding the effects of pressure and stretch on pain phenotypes in patients with oral cancers. This gap significantly hinders our understanding of the mechanisms underlying oral cancer pain. By quantitatively assessing the pressure and stretch sensitivities experienced by these patients, the investigators can gain valuable insights into the origins of their pain. In this proposal, the investigators hypothesize that the quality of pain experienced by oral cancer patients is influenced by the activation levels of mechanosensitive ion channels at the site of the cancer. The investigators will conduct sensitivity tests for pressure and stretch on oral cancer patients and compare the patients' sensitivities with those of healthy subjects. Furthermore, the investigators will evaluate the correlation between pressure and stretch sensitivity scores in oral cancer patients.
The investigators propose that the degree of pressure and stretch sensitivities experienced by oral cancer patients is quantifiable and depends on the functional expression of TRPV4 on Schwann cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer Subjects | Experimental | Behavioral: Pressure and stretch sensitivity testingOral 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. |
| Healthy Subjects | Active comparator | Behavioral: Pressure and stretch sensitivity testingHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- Healthy subjects who meet any of the following criteria will be excluded from participation in this 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure and stretch sensitivity testingWe 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. | Behavioural | Healthy Subjects, Oral Cancer Subjects |
Primary outcome
Pressure sensitivity
Time frame: Baseline
Pressure pain thresholds will be measured in kilopascals with a digital pressure algometer. The average of three measurements will be used to determine each threshold. Lower thresholds signify higher pain levels.
Stretch sensitivity
Time frame: Baseline
Stretch sensitivity will be evaluated by assessing pain or discomfort associated with tongue range of motions (tongue protrusion, tongue elevation, right lateralization and left lateralization).To measure stretch sensitivity, visual analog scale (VAS) scores for participants' pain associated with tongue stretching will be recorded. Participants will perform tongue range of motions (ROM): protrusion, elevation, and right and left lateralization, and they will rate their sensitivity on the VAS scale after holding each position for five seconds. Subjects will also rate the quality of their pain. Stretch sensitivity will be defined as the sum of VAS scores for protrusion, elevation, and right and left lateralization. The VAS goes from 0-100, 0 representing no pain and 100 representing the most intense pain imaginable.
1 secondary outcome
To determine whether patients with lower pressure pain thresholds report higher pain scores on the visual analog scale after tongue stretching.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 36369568Gormley M, Creaney G, Schache A, Ingarfield K, Conway DI. Reviewing the epidemiology of head and neck cancer: definitions, trends and risk factors. Br Dent J. 2022 Nov;233(9):780-786. doi: 10.1038/s41415-022-5166-x. Epub 2022 Nov 11.
- Background: PubMed 21972258Viet CT, Schmidt BL. Biologic mechanisms of oral cancer pain and implications for clinical therapy. J Dent Res. 2012 May;91(5):447-53. doi: 10.1177/0022034511424156. Epub 2011 Oct 4.
- Background: PubMed 30305456Szczot M, Liljencrantz J, Ghitani N, Barik A, Lam R, Thompson JH, Bharucha-Goebel D, Saade D, Necaise A, Donkervoort S, Foley AR, Gordon T, Case L, Bushnell MC, Bonnemann CG, Chesler AT. PIEZO2 mediates injury-induced tactile pain in mice and humans. Sci Transl Med. 2018 Oct 10;10(462):eaat9892. doi: 10.1126/scitranslmed.aat9892.
- Background: PubMed 23306656Nilius B, Voets T. The puzzle of TRPV4 channelopathies. EMBO Rep. 2013 Feb;14(2):152-63. doi: 10.1038/embor.2012.219. Epub 2013 Jan 11.
- Background: PubMed 39661703Mikesell AR, Isaeva E, Schulte ML, Menzel AD, Sriram A, Prahl MM, Shin SM, Sadler KE, Yu H, Stucky CL. Increased keratinocyte activity and PIEZO1 signaling contribute to paclitaxel-induced mechanical hypersensitivity. Sci Transl Med. 2024 Dec 11;16(777):eadn5629. doi: 10.1126/scitranslmed.adn5629. Epub 2024 Dec 11.
- Background: PubMed 12692122Suzuki M, Mizuno A, Kodaira K, Imai M. Impaired pressure sensation in mice lacking TRPV4. J Biol Chem. 2003 Jun 20;278(25):22664-8. doi: 10.1074/jbc.M302561200. Epub 2003 Apr 13.
- Background: PubMed 40144515Mulpuri Y, Tu NH, Inoue K, Harden G, Nicholson SJ, Seenauth A, Huang Y, Escobar KG, Moayedi Y, Bunnett NW, Albertson DG, Schmidt BL. TRPV4 activation in Schwann cells mediates mechanically induced pain of oral cancer. Front Pain Res (Lausanne). 2025 Mar 12;6:1532885. doi: 10.3389/fpain.2025.1532885. eCollection 2025.
- Background: PubMed 30815600Salvo E, Saraithong P, Curtin JG, Janal MN, Ye Y. Reciprocal interactions between cancer and Schwann cells contribute to oral cancer progression and pain. Heliyon. 2019 Feb 15;5(2):e01223. doi: 10.1016/j.heliyon.2019.e01223. eCollection 2019 Feb.
- Background: PubMed 30637626Goyal N, Skrdla P, Schroyer R, Kumar S, Fernando D, Oughton A, Norton N, Sprecher DL, Cheriyan J. Clinical Pharmacokinetics, Safety, and Tolerability of a Novel, First-in-Class TRPV4 Ion Channel Inhibitor, GSK2798745, in Healthy and Heart Failure Subjects. Am J Cardiovasc Drugs. 2019 Jun;19(3):335-342. doi: 10.1007/s40256-018-00320-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian L Schmidt, DDS principal investigator
NYU College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure and stretch sensitivity testing in people with Oral Cancer and Squamous Cell Carcinoma, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yatendra Mulpuri, PhD (424-230-4222, ym2891@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure sensitivity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07095608, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.