Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-02 @ 2:22 AM
Study NCT ID:
NCT03305302
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2017-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014062', 'term': 'Tongue Neoplasms'}], 'ancestors': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immortalised human taste bud cells, isolated from the fungiform tastebuds of patients with cancer of the mobile tongue.', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of the Tongue']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.\n\nMoreover, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 70 years old,\n* with cancer of the mobile tongue\n* requiring surgery\n\nExclusion Criteria:\n\n\\- chronic smokers'}, 'identificationModule': {'nctId': 'NCT03305302', 'briefTitle': 'Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL', 'orgStudyIdInfo': {'id': 'ZWETYENGA 2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sample of cancerous epithelium from the tongue', 'type': 'PROCEDURE', 'description': 'Harvesting and culture of cancerous epithelium from the surgical piece'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}