NCT03305302

Brief Summary

In terms of incidence, cancer of the tongue is one of the leading cancers in France. Moreover, this cancer is associated with physiological complications ranging from swallowing disorders to loss of taste. Following surgery, impaired perception of food taste may lead to cachexia. It is therefore necessary to carry out research in the field of impaired taste, notably with regard to the regeneration of taste buds. However, there is currently no available functional model of taste bud cells. It is therefore necessary to obtain a cell line of human taste cells. These immortalised human cells will allow us to better orient our investigations for applications in humans: search for and characterisation of "taste modifiers" synthesised using organic chemistry, able to trigger the perception of food in cases of taste loss or taste impairment. Moreover, given recent studies conducted by the investigating team proposing the existence of a fatty taste and its implication in obesity, the work of the team could be oriented towards the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of sugar. The availability of these chemical molecules would lead to a reduction in lipid intake as these agents contain no (or very few) calories. They will act as an organoleptic decoy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

October 4, 2017

Last Update Submit

September 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Immortalised human taste bud cells, isolated from the fungiform tastebuds of patients with cancer of the mobile tongue.

    through study completion, an average of 1 year

Interventions

Harvesting and culture of cancerous epithelium from the surgical piece

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing surgery

You may qualify if:

  • between 18 and 70 years old,
  • with cancer of the mobile tongue
  • requiring surgery

You may not qualify if:

  • \- chronic smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Tongue Neoplasms

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 9, 2017

Study Start

November 2, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations