Oropharynx CancerNCT05211427
Bitter Taste Receptors in Oropharynx Cancer
A study testing Biopsy in people with Oropharynx Cancer, run by Thomas Hummel at 1 site in Germany.
Trial summary
The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2021to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Oropharynx SCC for the patient group
- signed informed consent for all
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Smell and Taste Center, University Klinik Dresden
Dresden, Saxony
Thomas Hummel, Prof., 0351 458-2118, thomas.hummel@tu-dresden.de
About this study
Official title: Expression of Bitter Taste Receptors in Oropharynx Carcinoma
The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).
Read the detailed description
Goal setting The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).
The hypothesis is that oropharyngeal carcinomas express TAS2Rs and that their stimulation can induce apoptosis. The lower expression of certain TAS2Rs in the tumor cells could represent protection from apoptosis by stimulation with the bitter ligands. Alternatively, it could polymorphisms of the bitter taste receptors, which can influence their function independently of the expression. In order to address the question of general bitter sensitivity in more detail, the investigators are planning to carry out a bitter taste test on the test subjects.
methodology As this is a pilot study, the investigators limit the number of subjects to 10 patients with p-16 positive and negative oropharyngeal squamous cell carcinoma and 10 patients with acute recurrent tonsillitis or other benign pathology in pharynx. The expression analysis is carried out using qPCR and possibly immunohistochemical methods. Taste strips are used for the taste tests.
Cognitive interest The results of this study will provide important insight into the pathophysiology of oropharyngeal cancers and possibly all TAS2R-expressing cancers. In addition, this and further studies can create a theoretical basis for new therapeutic methods for this group of diseases.
- Conditions
- Oropharynx Cancer
- Being tested
- Biopsy
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsy of an oropharynx tumor or of a healthy oropharynx mucosa
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with oropharynx cancer Receives: Procedure: Biopsy |
| Healthy subjects | Experimental | Patients with non malignant pharynx pathology Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of TAS2-Receptors
relative concentration of TAS2Rs in mucosa and tumor
Measured: The day of surgery and the day before
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start23 Mar 2021
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Hummel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Hummel, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211427
- Sponsor's protocol ID
- ENTASTE
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the regulations of the publishing journal
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Bitter Taste Receptors in Oropharynx Carcinoma
- ClinicalTrials.gov ID
- NCT05211427
- Acronym / sponsor ID
- ENTASTE
- Conditions
- Oropharynx Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Thomas HummelUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Jan 2022 (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.
The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).
Detailed description
Goal setting The aim of this work is to investigate the expression of the bitter taste receptors in p16-positive and negative oropharyngeal carcinomas (in comparison to healthy, local tissue).
The hypothesis is that oropharyngeal carcinomas express TAS2Rs and that their stimulation can induce apoptosis. The lower expression of certain TAS2Rs in the tumor cells could represent protection from apoptosis by stimulation with the bitter ligands. Alternatively, it could polymorphisms of the bitter taste receptors, which can influence their function independently of the expression. In order to address the question of general bitter sensitivity in more detail, the investigators are planning to carry out a bitter taste test on the test subjects.
methodology As this is a pilot study, the investigators limit the number of subjects to 10 patients with p-16 positive and negative oropharyngeal squamous cell carcinoma and 10 patients with acute recurrent tonsillitis or other benign pathology in pharynx. The expression analysis is carried out using qPCR and possibly immunohistochemical methods. Taste strips are used for the taste tests.
Cognitive interest The results of this study will provide important insight into the pathophysiology of oropharyngeal cancers and possibly all TAS2R-expressing cancers. In addition, this and further studies can create a theoretical basis for new therapeutic methods for this group of diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: BiopsyPatients with oropharynx cancer |
| Healthy subjects | Experimental | Procedure: BiopsyPatients with non malignant pharynx pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Oropharynx SCC for the patient group
- signed informed consent for all
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BiopsyBiopsy of an oropharynx tumor or of a healthy oropharynx mucosa | Procedure or surgery | Healthy subjects, Patients |
Primary outcome
Expression of TAS2-Receptors
Time frame: The day of surgery and the day before
relative concentration of TAS2Rs in mucosa and tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided. Depending on the regulations of the publishing journal
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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. This study is not recruiting at the moment.
Smell and Taste Center, University Klinik Dresden
Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Oropharynx Cancer, run by Thomas Hummel at 1 site in Germany.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of TAS2-Receptors (time frame: The day of surgery and the day before). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2023.