Bitter Taste Receptors in Oropharynx Cancer
Primary Purpose
Oropharynx Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Oropharynx Cancer
Eligibility Criteria
Inclusion Criteria:
- Oropharynx SCC for the patient group
- signed informed consent for all
Exclusion Criteria:
-
Sites / Locations
- Smell and Taste Center, University Klinik DresdenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients
Healthy subjects
Arm Description
Patients with oropharynx cancer
Patients with non malignant pharynx pathology
Outcomes
Primary Outcome Measures
Expression of TAS2-Receptors
relative concentration of TAS2Rs in mucosa and tumor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05211427
Brief Title
Bitter Taste Receptors in Oropharynx Cancer
Official Title
Expression of Bitter Taste Receptors in Oropharynx Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Hummel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with oropharynx cancer
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Patients with non malignant pharynx pathology
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
Biopsy of an oropharynx tumor or of a healthy oropharynx mucosa
Primary Outcome Measure Information:
Title
Expression of TAS2-Receptors
Description
relative concentration of TAS2Rs in mucosa and tumor
Time Frame
The day of surgery and the day before
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Oropharynx SCC for the patient group
signed informed consent for all
Exclusion Criteria:
-
Facility Information:
Facility Name
Smell and Taste Center, University Klinik Dresden
City
Dresden
State/Province
Saxony
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hummel, Prof.
Phone
0351 458-2118
Email
thomas.hummel@tu-dresden.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on the regulations of the publishing journal
Learn more about this trial
Bitter Taste Receptors in Oropharynx Cancer
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