NCT05211427

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

January 11, 2022

Last Update Submit

March 14, 2023

Conditions

Oropharynx Cancer

Outcome Measures

Primary Outcomes (1)

  • Expression of TAS2-Receptors

    relative concentration of TAS2Rs in mucosa and tumor

    The day of surgery and the day before

Study Arms (2)

Patients

EXPERIMENTAL

Patients with oropharynx cancer

Procedure: Biopsy

Healthy subjects

EXPERIMENTAL

Patients with non malignant pharynx pathology

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

Biopsy of an oropharynx tumor or of a healthy oropharynx mucosa

Healthy subjectsPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oropharynx SCC for the patient group
  • signed informed consent for all

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smell and Taste Center, University Klinik Dresden

Dresden, Saxony, Germany

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Interdisciplinary Smell and Taste Centre

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 27, 2022

Study Start

March 23, 2021

Primary Completion

February 1, 2025

Study Completion

July 1, 2025

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

DE(1)