Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT03765333
Status:
RECRUITING
Last Update Posted:
2024-10-03
First Post:
2018-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GETNE Registration of Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hystopathological characteristics of the tumor', 'timeFrame': 'Baseline', 'description': 'Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.'}, {'measure': 'Situation of the tumor at first-diagnosis', 'timeFrame': 'Baseline', 'description': 'Local tumor, locoregional tumor or metastatic disease.'}, {'measure': 'Tumor-Node-Metastasis classification', 'timeFrame': 'Baseline', 'description': 'Based on the AJCC (American Joint Committee on Cancer) 2018 TNM system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.'}, {'measure': 'Tumor Stage', 'timeFrame': 'Baseline', 'description': 'From I to IV, based on the interpretation of the TNM classification and depending on the hystopathological characteristics of the tumor.'}], 'secondaryOutcomes': [{'measure': 'Patient situation at the end of treatment', 'timeFrame': '12 months', 'description': 'Results of clinical evaluation of the disease including complete response, partial response, stable disease, progression of disease or death'}, {'measure': 'Number of patients with BRAF mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on BRAF status and proportion of patients with mutated BRAF or native BRAF.'}, {'measure': 'Number of patients with RET mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on RET status and proportion of patients with mutated RET or native RET.'}, {'measure': 'Number of patients with PI3K mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on PI3K status and proportion of patients with mutated PI3K or native PI3K.'}, {'measure': 'Number of patients with RAS mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on RAS status and proportion of patients with mutated RAS or native RAS.'}, {'measure': 'Number of patients with PAX8/PAR mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on PAX8/PAR status and proportion of patients with mutated PAX8/PAR or native PAX8/PAR.'}, {'measure': 'Number of patients with P53 mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on P53 status and proportion of patients with mutated P53 or native P53.'}, {'measure': 'Number of patients with PTEN mutation', 'timeFrame': '12 months', 'description': 'Total patients with available results on PTEN status and proportion of patients with mutated PTEN or native PTEN.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'An epidemiological, observational, multicenter, cross-sectional, retrospective study on patients ≥ 18 years visited in the oncology services of the participating centers with diagnosis of primary thyroid cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 18 years visited in the oncology services of the participating centers that have a diagnosis of primary cancer located in the thyroid gland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years with diagnosis of differentiated, medullary or anaplastic thyroid cancer confirmed by histopathology.\n* Patients who agree to participate and are able to understand the information sheet and sign the informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Patients with other types of thyroid cancer or whose histopathological diagnosis has not been confirmed.\n* Patients who do not have the relevant basic information to be included in the study, according to the criteria of the principal investigator.'}, 'identificationModule': {'nctId': 'NCT03765333', 'briefTitle': 'GETNE Registration of Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Espanol de Tumores Neuroendocrinos'}, 'officialTitle': 'Descriptive Observational Epidemiological Study on the Characteristics of Thyroid Cancer in Patients Treated in Oncology Services of Spanish Centers: National Registry of Thyroid Cancer - Differentiated, Medullary and Anaplastic', 'orgStudyIdInfo': {'id': 'REGETNE-Tiroides'}}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person designated by the sponsor, M.D.', 'role': 'CONTACT', 'email': 'investigacion@mfar.net'}, {'name': 'Principal investigator selected by the sponsor, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Secretaria Técnica GETNE', 'role': 'CONTACT', 'email': 'getne@mfar.net', 'phone': '+34 93 434 44 12'}], 'overallOfficials': [{'name': 'Jorge Hernando Cubero, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Hospital Universitari Vall d'Hebron, Barcelona"}, {'name': 'Jaume Capdevila, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Hospital Universitari Vall d'Hebron, Barcelona"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Espanol de Tumores Neuroendocrinos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}